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

March 4, 2026 updated by: Wen-Tao Li, Fudan University
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
  2. Massive or diffuse hepatocellular carcinoma;
  3. Presence of vascular tumor thrombus or invasion of adjacent organs;
  4. History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
  5. Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
  6. Refractory massive ascites, cachexia;
  7. Active infection, especially inflammatory conditions of the biliary system;
  8. Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
  9. Impaired consciousness, or inability to cooperate with treatment;
  10. 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);
  11. Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Multimodal Tumor Thermal Ablation
Device: Multimodal Tumor Thermal Ablation
Multimodal Tumor Thermal Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation efficacy rate at 1 month postoperatively
Time Frame: 1 month after ablation
Ablation efficacy rate at 1 month postoperatively
1 month after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment
Time Frame: 1 month after ablation
Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment
1 month after ablation
Adverse events and serious adverse events
Time Frame: 1 month
Adverse events and serious adverse events
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTTIR-DHF-701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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