NCT03764293已完成3 期
A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 543
- 试验地点
- 121
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.
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
- None
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
- •Histopathologically or cytologically confirmed advanced HCC
- •No previous systematic treatment for HCC
- •Have at least one measurable lesion (in accordance with RECIST v1.1)
- •BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
- •ECOG-PS score 0 or 1
- •Child-Pugh Class: Grade A
- •Life Expectancy of at least 12 weeks
- •Subjects with HBV infection: HBV DNA<500 IU/ml or < 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
- •Subjects with HCV-RNA(+) must receive antiviral therapy
- •Adequate organ function
排除标准
- •Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
- •Moderate-to-severe ascites with clinical symptoms
- •History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- •Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- •Known genetic or acquired hemorrhage or thrombotic tendency
- •Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- •Cardiac clinical symptom or disease that is not well controlled
- •Hypertension that can not be well controlled through antihypertensive drugs
- •Factors to affect oral administration
- •History of hepatic encephalopathy
- •Previous or current presence of metastasis to central nervous system
- •HIV infection
- •Combined hepatitis B and hepatitis C co-infection
- •Be ready for or previously received organ or allogenic bone marrow transplantation
- •Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
- •Active known, or suspected autoimmune disease
- •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
- •Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
- •Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
- •Severe infection within 4 weeks prior to the start of study treatment
- •Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
- •Treatment of other investigational product(s) within 28 days prior to the start of study treatment
研究组 & 干预措施
SHR-1210
Experimental
SHR-1210+Apatinib
干预措施: SHR-1210 (Drug)
SHR-1210
Experimental
SHR-1210+Apatinib
干预措施: Apatinib (Drug)
Control
Active Comparator
Sorafenib
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 3 years
OS was defined as the time from randomization to death from any cause.
Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1
时间窗: Up to approximately 3 years
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Objective Response Rate (ORR)(Up to approximately 3 years)
- Duration of Response (DOR)(Up to approximately 3 years)
- Disease Control Rate (DCR)(Up to approximately 3 years)
研究者
研究点 (121)
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相关资讯
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- The combination therapy achieved a median overall survival of 23.8 months versus 15.2 months with sorafenib, representing a 36% reduction in death risk with manageable safety profile.
- The company plans to resubmit its New Drug Application to the FDA for the combination therapy in January 2026, potentially offering a new first-line treatment option for liver cancer patients.9 months agoElevar Therapeutics Plans NDA Resubmission for Rivoceranib/Camrelizumab in Unresectable HCC After CRL- Elevar Therapeutics plans to resubmit its NDA for rivoceranib plus camrelizumab to the FDA for treating unresectable hepatocellular carcinoma (HCC).
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