A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Assessment of immune activating response
研究概览
简要总结
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. This prospective, multi-center, randomized controlled clinical study aimed to explore the ablation-induced immune activating response of MTT in the treatment of malignant liver tumors.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-80 years.
- •Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers.
- •Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤
- •Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence.
- •Child-Pugh score ≤7 (Class A or B).
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification).
- •Life expectancy of at least 3 months.
- •Patients who have previously undergone surgery, chemotherapy, targeted therapy, ablation, vascular interventional therapy (TACE, D-TACE, HAIC), or immunotherapy, with an interval of ≥3 weeks since the last treatment.
- •The functional level of major organs must meet the following requirements:
- •(1) Blood Routine: WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥50×109/L，HGB≥90 g/L. (2) Liver Function: AST ≤5.0×ULN, ALT ≤5.0×ULN, TBIL ≤2.0×ULN. (3) Renal Function: Cr ≤1.5×ULN or CrCl ≥60 mL/min. (4) Coagulation Function: INR ≤1.5; APTT ≤1.5×ULN. (5) HBV-DNA: HBV-DNA ≤2×10³ IU/mL (*Patients with HBV-DNA >2×10³ IU/mL may be enrolled but must receive antiviral therapy.*)
排除标准
- •Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins.
- •Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1/3 of the liver volume.
- •Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding.
- •Active bacterial infection or fungal infection.
- •Previous or coexisting malignancies.
- •History of solid organ transplant or hepatic encephalopathy.
- •Current enrollment in another clinical trial or prior exposure to experimental therapies.
- •Pregnant or breastfeeding, or preparing to pregnant.
- •Not suitable to participate in clinical trials judged by investigator.
研究组 & 干预措施
Single Thermal Ablation
These patients will receive local ablation using the microwave ablation system or radiofrequency ablation system.
干预措施: Radiofrequency Ablation System or Microwave Ablation System (Device)
Multimodal Tumor Thermal Therapy
These patients will receive multimodal thermal therapy using multimodal tumor thermal therapy system.
干预措施: Multimodal Tumor Thermal Therapy System (Device)
结局指标
主要结局
Assessment of immune activating response
时间窗: In 6 months
The landscape of the peripheral immune response induced by local ablation in patients with malignant liver tumors.
Progression Free Survival (PFS)
时间窗: At 12 months after the ablation procedure on Day 0
PFS was defined as the time from the first ablation until local tumor progression, any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first).
次要结局
- Objective Response Rate（ORR）(At 6 months after the ablation procedure on Day 0)
- Local Control Rate（LCR）(At 6 months after the ablation procedure on Day 0)
- Overall Survival (OS)(At 36 months after the ablation procedure on Day 0)
- Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation(From time of first ablation (Day 0) up to 3 months post ablation)
研究者
Lichao Xu
Associate Chief Physician
Fudan University