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Recruiting NCT07159048

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

No phase Interventional Hepatocellular Carcinoma Colorectal Cancer Liver Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal Tumor Thermal Therapy System, Radiofrequency Ablation System or Microwave Ablation System.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Colorectal Cancer Liver Metastasis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • Progression Free Survival (PFS) [Time frame: At 12 months after the ablation procedure on Day 0]
  • Assessment of immune activating response [Time frame: In 6 months]
Secondary outcome measures (4)
  • Objective Response Rate（ORR） [Time frame: At 6 months after the ablation procedure on Day 0]
  • Local Control Rate（LCR） [Time frame: At 6 months after the ablation procedure on Day 0]
  • Overall Survival (OS) [Time frame: At 36 months after the ablation procedure on Day 0]
  • Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation [Time frame: From time of first ablation (Day 0) up to 3 months post ablation]

Eligibility criteria

Inclusion criteria

  • 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.\*)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University — Shanghai

Identifiers

NCT: NCT07159048 · 2025-308-4457

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗