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NOT YET RECRUITING
NCT07159048
NA

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-09-10

Completion Date

2027-10-31

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

DEVICE

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.

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.