Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

NCT07459309 | Recruiting

• 1 other identifier: MTTIR-DHF-701
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

Conditions

Liver Ablation; Liver Cancer (Primary and Metastatic)

Outcome Measures

Primary Outcomes (1)

• Ablation efficacy rate at 1 month postoperatively

  Ablation efficacy rate at 1 month postoperatively

  1 month after ablation

Secondary Outcomes (2)

• Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment

  1 month after ablation

• Adverse events and serious adverse events

  1 month

Study Arms (1)

Treatment Group

EXPERIMENTAL

Multimodal Tumor Thermal Ablation

Device: Multimodal Tumor Thermal Ablation

Interventions

Multimodal Tumor Thermal Ablation DEVICE

Multimodal Tumor Thermal Ablation

Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, regardless of gender;
• Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer;
• Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm;
• Patient is intolerant to or refuses surgical resection;
• ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.

You may not qualify if:

• Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
• Massive or diffuse hepatocellular carcinoma;
• Presence of vascular tumor thrombus or invasion of adjacent organs;
• History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
• Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
• Refractory massive ascites, cachexia;
• Active infection, especially inflammatory conditions of the biliary system;
• Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
• Impaired consciousness, or inability to cooperate with treatment;
• Previous systemic treatments (e.g., chemotherapy) with an interval of less than 2 weeks and not having recovered from prior treatment: CTCAE 6.0 grade \>1 (except for alopecia);
• Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

wentao li

CONTACT

+86 13774225887; liwentao98@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Therapy Department,Fudan University

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)