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

Official record

Identifier

NCT07159048

Recruiting locations

country

China

Interventions studied

Multimodal Tumor Thermal Therapy SystemRadiofrequency Ablation System or Microwave Ablation System

Lead sponsor

Fudan University

Target enrolment

120 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Sep 8, 2025

Last updated on the registry

Aug 10, 2026

Age

18 Years – 80 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Liver Cancer