A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With FOLFOX4 in Subjects With Advanced HCC Who Have Never Received Prior Systemic Treatment.

NCT ID: NCT03605706

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2023-12-31

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4.

The primary study hyposis is that Camrelizumab combined with FOLFOX4 treatment can improve Overall Survival when compared with placebo in combination with FOLFOX4 Regimen.

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR-1210

SHR-1210+FOLFOX4

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

FOLFOX4

Intervention Type: DRUG

Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks

CONTROL

SHR-1210+Placebo

Group Type: EXPERIMENTAL

FOLFOX4

Intervention Type: DRUG

Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks

Placebo

Intervention Type: DRUG

Subjects receive placebo of SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Interventions

SHR-1210

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Intervention Type: DRUG

FOLFOX4

Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks

Intervention Type: DRUG

Placebo

Subjects receive placebo of SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Has not received prior systemic treatment for their advanced/metastatic HCC. Has measurable disease according to RECIST v1.1. ECOG Performance Status of 0 or 1. Child-Pugh Class A or B with 7 points. Life Expectancy of at least 12 weeks. HBV DNA<500 IU/ml. Adequate organ function： Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.

Exclusion Criteria

Known fibrolamellar HCC, Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.

Known or occurrence of central nervous system (CNS) metastases. Ascites with clinical symptoms. Known or evidence of GI hemorrhage within the past 6 months. Known or occurrence of hemorrhage/ thrombus. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.

Grade III~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.

Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 150mmHg, diastolic blood pressure > 90 mmHg).

History of hepatic encephalopathy. Known history of human immunodeficiency virus (HIV) infection. Active infection or an unexplained fever > 38.5°C during screening visits. Prior or planning to organ transplantation including liver transplantation. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.

Proteinuria≥ 2+ and 24 hours total urine protein > 1.0 g. Active known, or suspected autoimmune disease. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.

Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.

Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.

Pregnant or breast-feeding women. According to the investigator, other conditions that may lead to stop the research.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shukui Qing, MD

Role: STUDY_CHAIR

China, Jiangsu 81 Hospital Nanjing

Locations

81 Hospital Nanjing

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Linna Wang, MD

Role: CONTACT

wanglinna@hrglobe.com

021-60453196

Facility Contacts

Shukui Qin, MD

Role: primary

+862580864542

Other Identifiers

SHR-1210-III-305-HCC

Identifier Type: -

Identifier Source: org_study_id