NCT04985136终止3 期
A Randomized, Open-Label, Controlled, International Multi-Center Phase III Clinical Study of Camrelizumab Combined With Rivoceranib (Apatinib) Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Hepatocellular Carcinoma (HCC) Who Have Been Treated With Immune Checkpoint Inhibitors (ICIs)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Stage I：Objective Response Rate（ORR）
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 Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (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
- •Subject must participate voluntarily and sign the informed consent form;
- •Aged ≥ 18 years old, male or female;
- •Histopathologically confirmed hepatocellular carcinoma;
- •Has PD on treatment with prior anti-PD-1/PD-L1/CTLA-4 monoclonal antibody (mAb) administered either as monotherapy or as combination therapy.
- •No more than 2 lines of previous system treatment;
- •Be able to provide fresh or archived tumor tissue samples;
- •Patient with at least one measurable lesion (for Stage I);
- •Barcelona clinic liver cancer: Stage B or C;
- •Child-Pugh score: ≤ 7;
- •ECOG PS score of 0-1;
- •Life expectancy of ≥ 12 weeks;
- •Adequate organ function
- •Must take one medically approved contraceptive measure
排除标准
- •Patients with any active, known or suspected autoimmune disorder;
- •Patients who have used corticosteroids or other immunosuppressive agents for systemic treatment within 1 month prior to randomization;
- •With known severe allergic reactions to any other monoclonal antibodies;
- •Received previous camrelizumab or rivoceranib mesylate treatment;
- •Patients who discontinued ICIs treatment due to immune-related toxicity;
- •Patients with known CNS metastasis or hepatic encephalopathy;
- •Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;;
- •Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before randomization;
- •Patients with other malignancies currently or within the past 5 years;
- •Patients with hypertension which cannot be well controlled by antihypertensives; history of hypertensive crisis or hypertensive encephalopathy;
- •Uncontrolled cardiac diseases or symptoms；
- •Known hereditary or acquired bleeding disorders;
- •Clinically significant bleeding symptoms or clear bleeding tendency;
- •Patients with gastrointestinal perforation or gastrointestinal fistula;
- •Patients with significant vascular invasions with a high possibility of fatal bleeding;
- •Patients with important arterial/venous thrombosis;
- •Patients experiencing toxicity caused by previous anti-tumor therapy that has not recovered to Grade ≤ 1;
- •Patients with active infection;
- •Patients with congenital or acquired immune deficiency;
- •Patients who received live vaccines within 28 days prior to randomization, or are expect to be vaccinated during the treatment period;
- •Patients with other potential factors that may affect the study results.
研究组 & 干预措施
camrelizumab + Rivoceranib
Experimental
干预措施: camrelizumab；Rivoceranib (Drug)
Rivoceranib
Active Comparator
干预措施: Rivoceranib (Drug)
Sorafenib
Active Comparator
干预措施: Sorafenib (Drug)
Regorafenib
Active Comparator
干预措施: Regorafenib (Drug)
结局指标
主要结局
Stage I：Objective Response Rate（ORR）
时间窗: 2.5 years
Stage II：Overall survival （OS）
时间窗: 2.5 years
次要结局
- Duration of Response（DoR）(2.5 years)
- Progression-Free-Survival （PFS）(2.5 years)
- time to progression （TTP）(2.5 years)
- Stage II：Objective Response Rate（ORR）(2.5 years)
- Adverse Events（AEs）(2.5 years)
- Disease Control Rate（DCR）(2.5 years)
- Pharmacokinetics (PK) Ctrough of camrelizumab(2.5 years)
- Pharmacokinetics (PK) Ctrough of Apatinib(2.5 years)
- Proportion of anti- camrelizumab antibody (ADA)(2.5 years)
- Stage I：Overall survival （OS）(2.5 years)
- Proportion of neutralizing antibody (Nab)(2.5 years)
研究者
研究点 (1)
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