NCT07159048

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2025-09-08
• Last updated: 2025-09-08