Multimodal Thermal Therapy for Malignant Liver Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, randomized controlled study evaluating the ablation-induced immune response from multimodal tumor thermal therapy in malignant liver tumors. Participants have hepatocellular carcinoma or liver metastases, with up to five lesions each 5 cm or smaller, no extrahepatic metastases, and adequate organ function. The intervention uses a multimodal thermal therapy system alongside standard ablation options such as radiofrequency or microwave ablation. The trial aims to determine safety, feasibility, and the immune-related effects of this approach, compared to appropriate control conditions. Eligible patients have preserved performance status, controlled prior treatments, and a life expectancy of at least three months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Lichao Xu, M.D — Fudan University
• Study coordinator: Lichao Xu, M.D
• Email: lichaoxu163@163.com
• Phone: : +86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.