EUCTR2019-000220-18-BE进行中（未招募）1 期
A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib (Rivoceranib) Mesylate Versus Sorafenib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 510
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- = 18 years old, male and female
- •- 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, prior to enrollment in the study
- •- Subjects with HCV-RNA(+) must receive antiviral therapy
- •- Adequate organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 357
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 153
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 or other gastrointestinal disorder with risk of bleeding
- •- 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
- •- 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/CYP2C19 inducers or inhibitors within 14 days prior to the start of study treatment
- •- Known history of hypersensitivity to the active substance or to any other components of each investigational medicinal product as SHR-1210, rivoceranib , sorafenib or other mAbs
- •- 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 or 5 half-lives (whichever comes later) prior to the start of study treatment
研究者
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