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

NCT07159048 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Not applicable

Started

2025-10-15

Last updated

2026-08-10

Condition(s) studied

Hepatocellular CarcinomaColorectal Cancer Liver Metastasis

Investigational drug(s) / intervention(s)

Multimodal Tumor Thermal Therapy SystemRadiofrequency Ablation System or Microwave Ablation System

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Age of 18-80 years. 2. Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers. 3. Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5. 4. Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence. 5. Child-Pugh score ≤7 (Class A or B). 6. Performance status 0-1 (Eastern Cooperative Oncology Group classification). 7. Life expectancy of at least 3 months. 8. 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. 9. 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: 1. Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins. 2. Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1/3 of the liver volume. 3. Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding. 4. Active bacterial infection or fungal infection. 5. Previous or coexisting malignancies. 6. History of solid organ transplant or hepatic encephalopathy. 7. Current enrollment in another clinical trial or prior exposure to experimental therapies. 8. Pregnant or breastfeeding, or preparing to pregnant. 9. Not suitable to participate in clinical trials judged by investigator.

Primary outcome measure(s)

Progression Free Survival (PFS) — 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).
Assessment of immune activating response — In 6 months
The landscape of the peripheral immune response induced by local ablation in patients with malignant liver tumors.

Trial sites (1)

Facility	City	Region	Status
Fudan University	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07159048 on ClinicalTrials.gov ↗ ← All trials in China