NCT03605706Unknown3 期
A Phase III, Multicentered, Randomized, Double-blinded, Parallel Controlled Study to Evaluate Camrelizumab (PD-1 Antibody) in Combination With FOLFOX4 Regimen Versus Placebo in Combination With FOLFOX4 Regime in First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has not received prior systemic treatment for their advanced/metastatic HCC. Has measurable disease according to RECIST v1.
- •ECOG Performance Status of 0 or
- •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.
排除标准
- •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.
研究组 & 干预措施
SHR-1210
Experimental
SHR-1210+FOLFOX4
干预措施: SHR-1210 (Drug)
SHR-1210
Experimental
SHR-1210+FOLFOX4
干预措施: FOLFOX4 (Drug)
CONTROL
Experimental
SHR-1210+Placebo
干预措施: FOLFOX4 (Drug)
CONTROL
Experimental
SHR-1210+Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to approximately 3 years
OS was defined as the time from randomization to death due to any cause
次要结局
- Objective Response Rate (ORR) per RECIST 1.1 in all participants(Up to approximately 6 months)
- 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)
- AE(Up to approximately 3 years)
- Disease Control Rate (DCR) per RECIST 1.1 in all participants(Up to approximately 3 years)
研究者
研究点 (1)
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