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

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma, Colorectal Cancer Liver Metastasis

In brief

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.

Key facts

Study ID

NCT07159048

Run by

Fudan University

People needed

120

Starts

2025-10-15

Expected to finish

2027-10-31

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≤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.*)

You may not qualify if…

• 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.

Where it is running

• Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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