Immune Checkpoint Inhibitors and Anti-Vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Interventional Therapy for Advanced HCC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- ORR, objective response rate
研究概览
简要总结
This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
- •Age ≥18 years at the time of signing informed consent, regardless of gender.
- •Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
- •BCLC Stage B or C.
- •At least one measurable lesion per RECIST 1.
- •ECOG score of 0-
- •Child-Pugh liver function class A or B.
- •Life expectancy ≥ 3 months.
- •Adequate hematological and organ function.
排除标准
- •Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
- •Pregnant or breastfeeding women.
- •Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
- •Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
- •History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
- •Presence of unhealed severe wounds, active ulcers, or untreated fractures.
- •Active autoimmune disease or history of autoimmune disorders.
- •Significant history of gastrointestinal diseases.
- •Significant history of cardiovascular or cerebrovascular diseases.
研究组 & 干预措施
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Apatinib (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Camrelizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Lenvatinib (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Pembrolizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Atezolizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Bevacizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Camrelizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Apatinib (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Tislelizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
干预措施: Sintilimab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Lenvatinib (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Pembrolizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Atezolizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Bevacizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: TACE (Procedure)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: HAIC (Procedure)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: DEB-TACE (Procedure)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Tislelizumab (Drug)
Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.
干预措施: Sintilimab (Drug)
结局指标
主要结局
ORR, objective response rate
时间窗: 12 months after the last subject is enrolled
次要结局
- DCR, disease control rate(12 months after the last subject is enrolled)
- PFS, progression free survival(12 months after the last subject is enrolled)
- Serious adverse events (SAE)(12 months after the last subject is enrolled)
- OS, overall survival(12 months after the last subject is enrolled)
- DoR, duration of response(12 months after the last subject is enrolled)
- Adverse events (AE)(12 months after the last subject is enrolled)