The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Multimodal Tumor Thermal Therapy System
  All subjects were treated with a multi-modal thermal therapy system (Shanghai MAaGI Medical Technology Co., Ltd.) following a temperature-controlled tumor ablation protocol. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status.
• Устройство Radiofrequency Ablation System or Microwave Ablation System
  All subjects were treated with a radiofrequency ablation system or microwave ablation System. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status.

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: At 12 months after the ablation procedure on Day 0]
• Assessment of immune activating response [Срок оценки: In 6 months]

Вторичные конечные точки (4)

• Objective Response Rate（ORR） [Срок оценки: At 6 months after the ablation procedure on Day 0]
• Local Control Rate（LCR） [Срок оценки: At 6 months after the ablation procedure on Day 0]
• Overall Survival (OS) [Срок оценки: At 36 months after the ablation procedure on Day 0]
• Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation [Срок оценки: From time of first ablation (Day 0) up to 3 months post ablation]

Критерии участия

Критерии включения

• Age of 18-75 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 ≤5.
• 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.\*)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University — Шанхай

Идентификаторы

NCT: NCT07159048 · 2025-308-4457

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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