Trial Outcomes & Findings for Safety and Tolerability Evaluation of Sintilimab in Combination With Radiation in Stage IV NSCLC Patients (NCT NCT03812549)

NCT ID: NCT03812549

Last Updated: 2025-03-04

Results Overview

Adverse Events and/or Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 29 participants
• Primary outcome timeframe: from randomization through 30 days after last dosing, up to 24 months
• Results posted on: 2025-03-04

Participant Flow

Participant milestones

Measure	Dose Level 1: 2Gy in 1 Fraction DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 2Gy/1f) + anti-PD-1 inhibitor 200mg.	Dose Level 2: 4Gy in 2 Fractions DOSE LEVEL 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 4Gy/2f) + anti-PD-1 inhibitor 200mg.	Dose Level 3: 10Gy in 5 Fractions DOSE LEVEL 3: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 10Gy/5f) + anti-PD-1 inhibitor 200mg.
Dose Level 1: 2Gy in 1 Fraction STARTED	6	0	0
Dose Level 1: 2Gy in 1 Fraction COMPLETED	6	0	0
Dose Level 1: 2Gy in 1 Fraction NOT COMPLETED	0	0	0
Dose Level 2: 4Gy in 2 Fractions STARTED	0	17	0
Dose Level 2: 4Gy in 2 Fractions COMPLETED	0	17	0
Dose Level 2: 4Gy in 2 Fractions NOT COMPLETED	0	0	0
Dose Level 3: 10Gy in 5 Fractions STARTED	0	0	6
Dose Level 3: 10Gy in 5 Fractions COMPLETED	0	0	6
Dose Level 3: 10Gy in 5 Fractions NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability Evaluation of Sintilimab in Combination With Radiation in Stage IV NSCLC Patients

Baseline characteristics by cohort

Measure	Dose Level 1: 2Gy in 1 Fraction n=6 Participants DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 2Gy/1f) + anti-PD-1 inhibitor 200mg.	Dose Level 2: 4Gy in 2 Fractions n=17 Participants DOSE LEVEL 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 4Gy/2f) + anti-PD-1 inhibitor 200mg.	Dose Level 3: 10Gy in 5 Fractions n=6 Participants DOSE LEVEL 3: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 10Gy/5f) + anti-PD-1 inhibitor 200mg.	Total n=29 Participants Total of all reporting groups
Age, Continuous	64.3 years n=5 Participants	68.2 years n=7 Participants	64.3 years n=5 Participants	65.0 years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	15 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	17 Participants n=7 Participants	6 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment China	6 participants n=5 Participants	17 participants n=7 Participants	6 participants n=5 Participants	29 participants n=4 Participants
smoking history	5 participants n=5 Participants	15 participants n=7 Participants	4 participants n=5 Participants	24 participants n=4 Participants
PD-L1 expression ≥ 50%	2 participants n=5 Participants	7 participants n=7 Participants	1 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: from randomization through 30 days after last dosing, up to 24 months

Adverse Events and/or Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Outcome measures

Measure	Dose Level 1: 2Gy in 1 Fraction n=6 Participants DOSE LEVEL: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose from 2 Gy to 10Gy + anti-PD-1 inhibitor 200mg. Therefore, there were 3 different dose levels. DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 2Gy/1f) + anti-PD-1 inhibitor 200mg.	Dose Level 2: 4Gy in 2 Fractions n=17 Participants DOSE LEVEL 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 4Gy/2f) + anti-PD-1 inhibitor 200mg.	Dose Level 3: 10Gy in 5 Fractions n=6 Participants DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 10Gy/5f) + anti-PD-1 inhibitor 200mg.
Number of Participants With Adverse Events and/or Dose Limiting Toxicities of Sintilimab in Combination With SBRT and LDRT Any TRAE Grade ≥ 3	0 Participants	5 Participants	1 Participants
Number of Participants With Adverse Events and/or Dose Limiting Toxicities of Sintilimab in Combination With SBRT and LDRT Any TRAE Grade < 3	6 Participants	12 Participants	5 Participants

SECONDARY outcome

Timeframe: up to 24 months after the enrollment

Investigator assessed PFS according to RECIST v1.1. Progression free survival is defined as time of enrollment to first evidence of progressive disease.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Dose Level 1: 2Gy in 1 Fraction n=6 Participants DOSE LEVEL: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose from 2 Gy to 10Gy + anti-PD-1 inhibitor 200mg. Therefore, there were 3 different dose levels. DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 2Gy/1f) + anti-PD-1 inhibitor 200mg.	Dose Level 2: 4Gy in 2 Fractions n=17 Participants DOSE LEVEL 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 4Gy/2f) + anti-PD-1 inhibitor 200mg.	Dose Level 3: 10Gy in 5 Fractions n=6 Participants DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 10Gy/5f) + anti-PD-1 inhibitor 200mg.
Progression Free Survival (PFS)	7.228 month Interval 0.0 to 17.323	9.035 month Interval 1.122 to 16.948	4.501 month Interval 0.0 to 12.861

SECONDARY outcome

Timeframe: up to 24 months after the enrollment

Population: objective response rate

Investigator assessed ORR using RECIST v1.1 including the all tumor, the tumor undergoing LDRT and the tumor which do not receive radiotherapy.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Dose Level 1: 2Gy in 1 Fraction n=6 Participants DOSE LEVEL: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose from 2 Gy to 10Gy + anti-PD-1 inhibitor 200mg. Therefore, there were 3 different dose levels. DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 2Gy/1f) + anti-PD-1 inhibitor 200mg.	Dose Level 2: 4Gy in 2 Fractions n=16 Participants DOSE LEVEL 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 4Gy/2f) + anti-PD-1 inhibitor 200mg.	Dose Level 3: 10Gy in 5 Fractions n=6 Participants DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 10Gy/5f) + anti-PD-1 inhibitor 200mg.
Objective Response Rate (ORR)	4 Participants	10 Participants	3 Participants

SECONDARY outcome

Timeframe: up to 24 months after the enrollment

Population: overall survival

OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause

Outcome measures

Measure	Dose Level 1: 2Gy in 1 Fraction n=6 Participants DOSE LEVEL: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose from 2 Gy to 10Gy + anti-PD-1 inhibitor 200mg. Therefore, there were 3 different dose levels. DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 2Gy/1f) + anti-PD-1 inhibitor 200mg.	Dose Level 2: 4Gy in 2 Fractions n=17 Participants DOSE LEVEL 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 4Gy/2f) + anti-PD-1 inhibitor 200mg.	Dose Level 3: 10Gy in 5 Fractions n=6 Participants DOSE LEVEL 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT, 10Gy/5f) + anti-PD-1 inhibitor 200mg.
Overall Survival (OS)	NA years insufficient number of participants with events	NA years insufficient number of participants with events	15.639 years Interval 0.0 to 32.8

Adverse Events

Dose Level 1

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Level 2

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Dose Level 3

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Level 1 n=6 participants at risk Dose level 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose at 2Gy/1f + anti-PD-1 inhibitor 200mg.	Dose Level 2 n=17 participants at risk Dose level 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose at 4Gy/2f + anti-PD-1 inhibitor 200mg.	Dose Level 3 n=6 participants at risk Dose level 3: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose at 10Gy/5f + anti-PD-1 inhibitor 200mg.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	5.9% 1/17 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	0.00% 0/17 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	16.7% 1/6 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	5.9% 1/17 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Metabolism and nutrition disorders Lipase increased	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	5.9% 1/17 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
General disorders Anaphylaxis	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	5.9% 1/17 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Endocrine disorders Hypoadrenocorticism	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	5.9% 1/17 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Other adverse events

Measure	Dose Level 1 n=6 participants at risk Dose level 1: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose at 2Gy/1f + anti-PD-1 inhibitor 200mg.	Dose Level 2 n=17 participants at risk Dose level 2: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose at 4Gy/2f + anti-PD-1 inhibitor 200mg.	Dose Level 3 n=6 participants at risk Dose level 3: Stereotactic body radiation therapy (SBRT) dose at 30 Gy/3f + Low Dose Radiotherapy (LDRT) dose at 10Gy/5f + anti-PD-1 inhibitor 200mg.
Endocrine disorders Hypothyroidism	50.0% 3/6 • Number of events 3 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	35.3% 6/17 • Number of events 6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	16.7% 1/6 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Hepatobiliary disorders ALT increased	50.0% 3/6 • Number of events 3 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	29.4% 5/17 • Number of events 5 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	16.7% 1/6 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Hepatobiliary disorders AST increased	33.3% 2/6 • Number of events 2 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	23.5% 4/17 • Number of events 4 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	50.0% 3/6 • Number of events 3 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Blood and lymphatic system disorders Hypoproteinemia	16.7% 1/6 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	11.8% 2/17 • Number of events 2 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	66.7% 4/6 • Number of events 4 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	17.6% 3/17 • Number of events 3 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	33.3% 2/6 • Number of events 2 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Cardiac disorders Cardiac arrhythmia	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	23.5% 4/17 • Number of events 4 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	33.3% 2/6 • Number of events 2 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
General disorders Fatigue	0.00% 0/6 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	17.6% 3/17 • Number of events 3 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	33.3% 2/6 • Number of events 2 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Endocrine disorders ACTH increased	33.3% 2/6 • Number of events 2 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	11.8% 2/17 • Number of events 2 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	16.7% 1/6 • Number of events 1 • from randomization through 30 days after last dosing，up to 24 months Adverse events (AEs) were monitored during the study and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Additional Information

Prof. You Lu

West China Hospital, Sichuan University

Phone: 13398179653

Email: radyoulu@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place