Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) according to RECIST 1.1 and mRECIST
研究概览
简要总结
This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.
详细描述
This study aims to evaluate the efficacy and safety of multimodal ablation combined with Tislelizumab, lenvatinib, and TACE in the treatment of primary liver cancer. By comparing preoperative and postoperative immune markers, the study seeks to clarify the clinical value of multimodal ablation combined with systemic therapy and TACE in the management of primary liver cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, regardless of gender.
- •Clinically or pathologically confirmed HCC.
- •CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
- •Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor >5 cm.
- •Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..
- •ECOG PS 0-1 and an expected survival >3 months.
- •Child-Pugh score ≤7.
排除标准
- •Child-Pugh class C liver dysfunction.
- •Tumor thrombus in the main portal vein or hepatic vein.
- •Extensive metastatic disease with an expected survival <3 months.
- •Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).
- •History of esophageal/gastric variceal bleeding within the past month.
- •History of other malignancies.
- •Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within <1 month.
- •Active infection; HBV co-infection (HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.
- •History of organ transplantation or hepatic encephalopathy.
- •Uncorrectable coagulation disorders.
- •Refractory massive ascites, pleural effusion, or cachexia.
- •Pregnancy, impaired consciousness, or inability to comply with treatment.
- •High tumor burden (sum of the largest liver lesion diameter and number of liver lesions >12).
- •Any other condition deemed unsuitable by investigators that may affect study participation.
研究组 & 干预措施
Treatment Group
The patient will receive induction therapy with tislelizumab and lenvatinib within 14 days after enrollment. Subsequently, within 2-7 days (the exact timing will be determined based on clinical circumstances), they will undergo Multimodal Thermal Therapy (MTT). Following the MTT procedure, on-demand TACE treatment will be administered. Starting from day 7 post-MTT (with the exact timing adjusted according to clinical conditions), the patient will resume tislelizumab and lenvatinib therapy until disease progression, occurrence of intolerable toxicity, or withdrawal of consent.
干预措施: Multimodal Thermal Therapy (Device)
结局指标
主要结局
Objective response rate (ORR) according to RECIST 1.1 and mRECIST
时间窗: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using RECIST 1.1 and mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
次要结局
- Progression-Free Survival（PFS）(Follow-up for 12 months,with assessments conducted every 3 months.)
- Overall Survival（OS）(Follow-up for 12 months,with assessments conducted every 3 months.)
- Safety and Tolerability(Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.)