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

NCT07159048 | Not Yet Recruiting

• 1 other identifier: 2025-308-4457
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatocellular Carcinoma; Colorectal Cancer Liver Metastasis

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  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).

  At 12 months after the ablation procedure on Day 0

• Assessment of immune activating response

  The landscape of the peripheral immune response induced by local ablation in patients with malignant liver tumors.

  In 6 months

Secondary Outcomes (4)

• Objective Response Rate（ORR）

  At 6 months after the ablation procedure on Day 0

• Local Control Rate（LCR）

  At 6 months after the ablation procedure on Day 0

• Overall Survival (OS)

  At 36 months after the ablation procedure on Day 0

• Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation

  From time of first ablation (Day 0) up to 3 months post ablation

Study Arms (2)

Multimodal Tumor Thermal Therapy

EXPERIMENTAL

These patients will receive multimodal thermal therapy using multimodal tumor thermal therapy system.

Device: Multimodal Tumor Thermal Therapy System

Single Thermal Ablation

EXPERIMENTAL

These patients will receive local ablation using the microwave ablation system or radiofrequency ablation system.

Device: Radiofrequency Ablation System or Microwave Ablation System

Interventions

Multimodal Tumor Thermal Therapy System DEVICE

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.

Multimodal Tumor Thermal Therapy

Radiofrequency Ablation System or Microwave Ablation System DEVICE

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.

Single Thermal Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.\*)

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.

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Zhongshan Hospital: collaborator
• Ruijin Hospital: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Lichao Xu, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lichao Xu, M.D

CONTACT

: +86-021-64175590; lichaoxu163@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share