A Prospective, Randomized, Open-Label, Multicenter Phase III Trial Evaluating the Efficacy and Safety of Transarterial Chemoembolization Combined With an Oral Triple-Agent Cocktail Regimen Versus Transarterial Chemoembolization Combined With First-Line Targeted Therapy Plus Immunotherapy in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 222
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a prospective, multicenter, randomized, open-label phase 3 study evaluating the efficacy and safety of transarterial chemoembolization (TACE) combined with a triple oral cocktail regimen versus TACE combined with targeted therapy plus immunotherapy as first-line treatment for unresectable 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
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years at the time of enrollment.
- •Diagnosis of hepatocellular carcinoma (HCC) established according to the Chinese National Liver Cancer (CNLC) guidelines, based on imaging findings and/or histopathological confirmation.
- •Not eligible for curative treatment, including surgical resection, local ablation, or liver transplantation.
- •No prior treatment for HCC, including any locoregional or systemic anticancer therapies.
- •Child-Pugh liver function class A or B 7.
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
Arm A: apatinib + camrelizumab + TACE
Participants will receive apatinib plus camrelizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
干预措施: Apatinib (Drug)
Arm A: apatinib + camrelizumab + TACE
Participants will receive apatinib plus camrelizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
干预措施: Camrelizumab (Drug)
Arm A: apatinib + camrelizumab + TACE
Participants will receive apatinib plus camrelizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
干预措施: TACE (Device)
Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE
Participants assigned to this arm will receive an oral triple-agent regimen consisting of thalidomide, capecitabine, and compound cantharides capsules. The oral regimen will be initiated immediately after the initial transarterial chemoembolization (TACE) procedure and administered continuously thereafter.
干预措施: TACE (Device)
Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE
Participants assigned to this arm will receive an oral triple-agent regimen consisting of thalidomide, capecitabine, and compound cantharides capsules. The oral regimen will be initiated immediately after the initial transarterial chemoembolization (TACE) procedure and administered continuously thereafter.
干预措施: Thalidomide (drug) (Drug)
Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE
Participants assigned to this arm will receive an oral triple-agent regimen consisting of thalidomide, capecitabine, and compound cantharides capsules. The oral regimen will be initiated immediately after the initial transarterial chemoembolization (TACE) procedure and administered continuously thereafter.
干预措施: Capecitabine (Drug)
Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE
Participants assigned to this arm will receive an oral triple-agent regimen consisting of thalidomide, capecitabine, and compound cantharides capsules. The oral regimen will be initiated immediately after the initial transarterial chemoembolization (TACE) procedure and administered continuously thereafter.
干预措施: Compound cantharides capsule (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to ~4 years
Overall survival is defined as the time from randomization to death from any cause. OS will be assessed in the intention-to-treat (ITT) population, which includes all randomized participants.
次要结局
- Time to Progression (TTP)(Up to ~2 years)
- Health-Related Quality of Life (HRQoL)(Up to ~2 years)
- Progression-Free Survival (PFS)(Up to ~2 years)
- Objective Response Rate (ORR)(Up to ~2 years)
- Duration of Response (DOR)(Up to ~2 years)
研究者
Jinglin Xia
Professor
Shanghai Zhongshan Hospital