TACE Combined With Camrelizumab and Apatinib Versus TACE in Intermediate and Advanced Hepatocelluar Carcinoma: a Randomized, Open-label, Multi-center Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) by investigator
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.
详细描述
This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).
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
- •Has a diagnosis of HCC confirmed by radiology, histology, or cytology
- •China liver cancer staging: Ib-IIIa
- •Child-Pugh score ≤6 point
- •Previous TACE treatment(≤2 times) is permitted
- •Adequate organ and marrow function
排除标准
- •Participants who had another previous or current malignant tumor, except for early-stage cancer with low risk of recurrence or a malignant tumor curatively treated >5 years prior to enrolment with no recurrence
- •Participants who have severe allergy to iodine, and unable to receive TACE
- •Participants who have undergone a liver transplant or allogeneic bone marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
- •Participants who had congenital or acquired immune deficiency, such as HIV infection
- •Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
- •Participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism
研究组 & 干预措施
Experimental group: TACE+Camrelizumab+Apatinib
Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE
干预措施: Camrelizumab (Drug)
Experimental group: TACE+Camrelizumab+Apatinib
Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE
干预措施: TACE (Device)
Experimental group: TACE+Camrelizumab+Apatinib
Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE
干预措施: Apatinib (Drug)
Control group: TACE
TACE
干预措施: TACE (Device)
结局指标
主要结局
Progression-free survival (PFS) by investigator
时间窗: Up to ~2 years
PFS is defined as the time from randomization to progression or death from any cause. Progression in this trial was determined as untreatable (UnTACEable) progression, defined as the inability of a patients to further receive or benefit from TACE for reasons. Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.
次要结局
- PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)(Up to ~2 years)
- Overall Survival (OS)(Up to ~4 years)
- Time to untreatable (unTACEable) progression (TTUP) by investigator(Up to ~2 years)
研究者
Gao-jun Teng
Chief physician
Zhongda Hospital