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.

Phase 3

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Drug: SHR-1210; Drug: Placebo; Drug: FOLFOX4

• Registration Number: NCT03605706
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-22
• Study First Posted: 2018-07-30
• Study Start: 2019-05-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10
• Primary Completion: 2023-02
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 396

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	Placebo	SHR-1210+Placebo
SHR-1210	SHR-1210	SHR-1210+FOLFOX4
SHR-1210	FOLFOX4	SHR-1210+FOLFOX4
CONTROL	FOLFOX4	SHR-1210+Placebo

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to approximately 3 years	OS was defined as the time from randomization to death due to any cause

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) per RECIST 1.1 in all participants	Up to approximately 6 months	ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Duration of Response (DoR) per RECIST 1.1 in all participants	Up to approximately 3 years
Progression-free Survival (PFS) per RECIST 1.1 in all participants	Up to approximately 3 years
Overall Survival (OS) rate at 9 months and 12 months	Up to approximately 9 months and 12 months
Time to Progression (TTP) per RECIST 1.1 in all participants	Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1 in all participants	Up to approximately 3 years
AE	Up to approximately 3 years

Trial Locations

Locations (1)

81 Hospital Nanjing; 🇨🇳 Nanjing, Jiangsu, China