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

NCT ID: NCT07159048

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2027-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multimodal Tumor Thermal Therapy

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

Group Type: EXPERIMENTAL

Multimodal Tumor Thermal Therapy System

Intervention Type: 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.

Single Thermal Ablation

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

Group Type: EXPERIMENTAL

Radiofrequency Ablation System or Microwave Ablation System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age of 18-75 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Lichao Xu

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lichao Xu, M.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Lichao Xu, M.D

Role: CONTACT

lichaoxu163@163.com

: +86-021-64175590

Other Identifiers

2025-308-4457

Identifier Type: -

Identifier Source: org_study_id