A Prospective, Non-interventional Study of TACE Combined With PD-1 Inhibitor in Patients With Advanced Hepatocellular Carcinoma: Efficacy and Immune Microenvironment Dynamics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
研究概览
简要总结
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in Patients with Advanced Hepatocellular Carcinoma treated with TACE Combined with PD-1 Inhibitor.
详细描述
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in Patients with Advanced Hepatocellular Carcinoma treated with TACE Combined with PD-1 Inhibitor. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
- •BCLC stage C, and stage B who are not amenable to curative or locoregional therapies.
- •Diagnosis of hepatocellular carcinoma.
- •At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI.
- •No prior anticancer therapy, including TACE/HAIC, chemotherapy, targeted therapy, or immunotherapy).
- •Planned to receive TACE plus anti-PD1 inhibitor as first-line treatment.
- •ECOG performance status 0-
- •Adequate organ function:
- •ANC ≥1.5 × 10⁹/L, platelets ≥60 × 10⁹/L, hemoglobin ≥9 g/dL.
- •Total bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN (≤5 × ULN if liver metastases).
- •Creatinine ≤1.5 × ULN or CrCl ≥60 mL/min.
- •Willing to provide archival/fresh tumor tissue and peripheral blood samples.
- •Signed informed consent.
排除标准
- •Prior systemic therapy.
- •Active autoimmune disease requiring immunosuppression.
- •Active infection requiring IV antibiotics.
- •HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).
- •Symptomatic CNS metastases.
- •Pregnancy/lactation.
- •Any condition compromising protocol compliance or data interpretation per investigator.
研究组 & 干预措施
TACE+PD1 inhibitor
干预措施: PD-1 inhibitor (Drug)
TACE+PD1 inhibitor
干预措施: TACE (Procedure)
结局指标
主要结局
Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
时间窗: max 24 months
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.
次要结局
- Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(max 24 months)
- Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(max 24 months)
- Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(max 24 months)
- Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(max 42 months)
- Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1(max 24 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(max 42 months)