NCT04639180进行中（未招募）3 期
A Randomized, Open-Label, Multi-Center, Phase Ⅲ Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 687
- 试验地点
- 6
- 主要终点
- Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)
研究概览
简要总结
A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Subjects with a histopathological diagnosis of HCC
- •Subjects who have undergone a curative resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only)
- •No previous systematic treatment and locoregional therapy for HCC prior to randomization
- •Absence of major macrovascular invasion
- •No extrahepatic spread
- •Full recovery from Curative resection or ablation within 4 weeks prior to randomization
- •High risk for HCC recurrence after resection or ablation
- •For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
- •Child-Pugh Class: Grade A
- •ECOG-PS score: 0 or 1
- •Subjects with HCV- RNA (+) must receive antiviral therapy
- •Adequate organ function
排除标准
- •Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously
- •Evidence of residual lesion, recurrence, and metastasis at randomization;
- •Moderate-to-severe ascites with clinical symptoms
- •History of hepatic encephalopathy
- •History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage
- •Active or history of autoimmune disease
- •Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
- •Cardiac clinical symptom or cardiovascular disease that is not well controlled
- •Severe infection within 4 weeks prior to the start of study treatment
- •HIV infection
- •Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
- •Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- •Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- •Known genetic or acquired hemorrhage or thrombotic tendency
- •Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- •Serious non-healing or dehiscing wound
- •Major Curative procedure within four weeks
- •Factors to affect oral administration
- •Previous or current presence of metastasis to central nervous system
研究组 & 干预措施
Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))
Experimental
Drug: Camrelizumab; Drug: Rivoceranib (Apatinib)
干预措施: Camrelizumab (Drug)
Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))
Experimental
Drug: Camrelizumab; Drug: Rivoceranib (Apatinib)
干预措施: Rivoceranib (Apatinib) (Drug)
结局指标
主要结局
Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)
时间窗: Randomization up to approximately 43 months
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
次要结局
- Time to Recurrence (TTR) as determined by the investigator and by BIRC(Randomization up to approximately 43 months)
- RFS Rate at 24 and 36 Months, as Assessed by the Investigator(Randomization up to 24 months and up to 36 months)
- Overall Survival (OS)(Randomization up to approximately 43 months)
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0(Baseline up to approximately 43 months)
研究者
研究点 (6)
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