Trial Outcomes & Findings for A Study to Evaluate SHR-1210 in Subjects With Advanced HCC (NCT NCT02989922)

Last Updated: 2024-03-15

Results Overview

Tumour responses were evaluated by the independent review committee (IRC) according to RECIST 1.1.The primary endpoints were the proportion of patients with a IRC-assessed objective response (defined as the percentage of patients whose best overall response was confirmed complete or partial response).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

220 participants

Primary outcome timeframe

approximate 3 years

Results posted on

2024-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	SHR-1210 Q2W Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Overall Study STARTED	111	109
Overall Study Treated	109	108
Overall Study COMPLETED	72	81
Overall Study NOT COMPLETED	39	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SHR-1210 Q2W n=109 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Total n=217 Participants Total of all reporting groups
Age, Continuous	48.0 years n=109 Participants	49.5 years n=108 Participants	49.0 years n=217 Participants
Sex: Female, Male Female	11 Participants n=109 Participants	10 Participants n=108 Participants	21 Participants n=217 Participants
Sex: Female, Male Male	98 Participants n=109 Participants	98 Participants n=108 Participants	196 Participants n=217 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	109 participants n=109 Participants	108 participants n=108 Participants	217 participants n=217 Participants

PRIMARY outcome

Timeframe: approximate 3 years

Outcome measures

Outcome measures
Measure	SHR-1210 Q2W n=109 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Objective Response Rate	11.9 percentage of participants Interval 6.5 to 19.5	16.7 percentage of participants Interval 10.2 to 25.1

PRIMARY outcome

Timeframe: from the date of the first dose to 6 months

6-month overall survival rate (defined as cumulative overall survival rate from the date of the first dose to 6 months)

Outcome measures

Outcome measures
Measure	SHR-1210 Q2W n=109 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
6-month Overall Survival Rate	75.9 percentage of participants Interval 66.6 to 82.9	73.0 percentage of participants Interval 63.6 to 80.4

SECONDARY outcome

Timeframe: approximate 3 years

time from first response to progression or death base on the IRC assessment

Outcome measures

Outcome measures
Measure	SHR-1210 Q2W n=109 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Duration of Response	30.4 months Interval 2.8 to not reached (due to insufficient number of subjects with events).	30.5 months Interval 5.4 to not reached (due to insufficient number of subjects with events).

SECONDARY outcome

Timeframe: approximate 3 years

Number of Subjects with one or more adverse events as assessed by CTCAE 4.03

Outcome measures

Outcome measures
Measure	SHR-1210 Q2W n=109 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Adverse Events	109 participants	108 participants

SECONDARY outcome

Timeframe: approximate 3 years

Time from first dose to death from any cause

Outcome measures

Outcome measures
Measure	SHR-1210 Q2W n=109 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 Participants Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Overall Survival	14.3 months Interval 11.5 to 19.5	13.2 months Interval 9.4 to 16.3

Adverse Events

SHR-1210 Q2W

Serious events: 50 serious events

Other events: 108 other events

Deaths: 27 deaths

SHR-1210 Q3W

Serious events: 46 serious events

Other events: 107 other events

Deaths: 29 deaths

Serious adverse events

Other adverse events

Additional Information

Linna Wang

Jiangsu HengRui Pharmaceuticals Co., Ltd

Phone: +862161053363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	SHR-1210 Q2W n=109 participants at risk Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 participants at risk Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
General disorders Disease progression	11.9% 13/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	8.3% 9/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
General disorders Multiple organ dysfunction syndrome	2.8% 3/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	2.8% 3/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
General disorders Death	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	1.9% 2/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
General disorders Pain	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Hepatic function abnormal	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	5.6% 6/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Hepatic failure	3.7% 4/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	2.8% 3/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Jaundice cholestatic	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Autoimmune hepatitis	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Cholecystitis	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Liver injury	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	2.8% 3/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	1.9% 2/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	3.7% 4/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	1.9% 2/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour rupture	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	3.7% 4/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Ascites	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Oral reactive capillary endothelial proliferation	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Gastric haemorrhage	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Subileus	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Aspartate aminotransferase increased	2.8% 3/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Alanine aminotransferase increased	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood bilirubin increased	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Platelet count decreased	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood glucose increased	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Gamma-glutamyltransferase increased	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Neutrophil count decreased	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	1.9% 2/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Infections and infestations Lung infection	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Infections and infestations Upper respiratory tract infection	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Infections and infestations Abdominal infection	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Infections and infestations Pneumonia	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Infections and infestations Splenic abscess	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.00% 0/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	0.93% 1/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.

Other adverse events
Measure	SHR-1210 Q2W n=109 participants at risk Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	SHR-1210 Q3W n=108 participants at risk Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Metabolism and nutrition disorders Decreased appetite	20.2% 22/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	17.6% 19/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Blood and lymphatic system disorders Anaemia	24.8% 27/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	25.9% 28/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Endocrine disorders Hypothyroidism	12.8% 14/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	12.0% 13/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Endocrine disorders Hyperthyroidism	5.5% 6/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	5.6% 6/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Diarrhoea	15.6% 17/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	18.5% 20/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Abdominal distension	10.1% 11/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	13.9% 15/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Ascites	11.0% 12/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	12.0% 13/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Abdominal pain	10.1% 11/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	9.3% 10/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Abdominal pain upper	6.4% 7/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	12.0% 13/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Nausea	9.2% 10/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	7.4% 8/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Gastrointestinal disorders Constipation	4.6% 5/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	5.6% 6/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
General disorders Pyrexia	23.9% 26/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	21.3% 23/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
General disorders Asthenia	21.1% 23/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	21.3% 23/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
General disorders Oedema peripheral	6.4% 7/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	5.6% 6/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
General disorders Chest pain	6.4% 7/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	3.7% 4/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Hepatic function abnormal	9.2% 10/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	13.9% 15/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Hepatobiliary disorders Jaundice	2.8% 3/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	8.3% 9/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Infections and infestations Upper respiratory tract infection	15.6% 17/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	11.1% 12/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Infections and infestations Urinary tract infection	2.8% 3/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	7.4% 8/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Aspartate aminotransferase increased	47.7% 52/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	44.4% 48/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Alanine aminotransferase increased	43.1% 47/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	42.6% 46/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood bilirubin increased	36.7% 40/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	35.2% 38/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Platelet count decreased	32.1% 35/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	36.1% 39/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations White blood cell count decreased	22.0% 24/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	28.7% 31/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Neutrophil count decreased	21.1% 23/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	24.1% 26/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Weight increased	24.8% 27/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	19.4% 21/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Bilirubin conjugated increased	22.9% 25/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	18.5% 20/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Gamma-glutamyltransferase increased	15.6% 17/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	25.9% 28/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood alkaline phosphatase increased	16.5% 18/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	19.4% 21/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Weight decreased	12.8% 14/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	15.7% 17/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood albumin decreased	11.9% 13/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	10.2% 11/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood lactate dehydrogenase increased	8.3% 9/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	13.9% 15/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Lymphocyte count decreased	9.2% 10/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	12.0% 13/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood thyroid stimulating hormone increased	10.1% 11/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	9.3% 10/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Lipase increased	6.4% 7/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	11.1% 12/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Blood bilirubin unconjugated increased	7.3% 8/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	9.3% 10/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Hepatitis B DNA increased	6.4% 7/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	10.2% 11/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Protein urine present	4.6% 5/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	7.4% 8/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations Neutrophil count increased	1.8% 2/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	7.4% 8/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Investigations White blood cell count increased	0.92% 1/109 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.	8.3% 9/108 • approximate 3 years Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.