Multi-mode Ablation and Molecular Imaging Multi-omics Study for Digestive-Origin Malignant Liver Tumors

NCT06588569 | Active Not Recruiting

• 1 other identifier: IR20210728
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, parallel-controlled clinical trial aims to establish a multi-mode ablation system for liver malignant tumors originating from the digestive system. The study will evaluate the safety and efficacy of multi-mode tumor ablation, utilizing a multi-mode imaging platform for ablation planning and immediate evaluation of intraoperative ablation effects. Additionally, the study will employ multi-omics and multi-mode imaging techniques to explore the spatiotemporal heterogeneity and immune escape mechanisms of liver metastases from gastrointestinal tumors, providing guidance for treatment strategy formulation and prognostic evaluation.

Conditions

Primary Liver Cancer; Colorectal Cancer Liver Metastases

Outcome Measures

Primary Outcomes (2)

• Antitumor immune response

  Antitumor immune response is a measure that evaluates the efficacy of multi-mode ablation in activating a durable and specific immune response against tumor cells. This outcome will be assessed as follows: Flow cytometry to quantify the proportions and absolute numbers of immune cell subsets, including CD4+ T cells, CD8+ T cells, NK cells, B cells and dendritic cells (DCs), as well as the immune suppressive myeloid-derived suppressor cells (MDSCs). Cytokine profiling is performed to measure the levels of immune-related cytokines such as interferon-gamma (IFN-γ), interleukin-2 (IL-2), and tumor necrosis factor-alpha (TNF-α). Assessment of immune memory phenotypes through the analysis of T cell receptor (TCR) repertoire diversity and clonality.

  max 24 months

• 6-month Disease Control Rate

  6-month Disease Control Rate (6-month DCR) refers to the proportion of patients who have a complete response (CR), partial response (PR), or stable disease (SD) at the 6-month follow-up visit.

  6 months

Secondary Outcomes (3)

• 6-Month Progression-Free Survival

  6 months

• 1-Year Progression-Free Survival

  1 year

• 1-Year Overall Survival

  1 year

Study Arms (2)

Multi-mode Ablation

EXPERIMENTAL

This arm includes patients with primary liver cancer or colorectal cancer liver metastasis (five cases each, totaling ten cases) who will receive multi-mode ablation, a novel ablation therapy that combines cryoablation and radiofrequency ablation.

Device: Multi-mode tumor treatment system

Conventional Radiofrequency Ablation

ACTIVE COMPARATOR

This arm includes patients with primary liver cancer or colorectal cancer liver metastasis (five cases each, totaling ten cases) who will receive conventional radiofrequency ablation treatment.

Device: Radiofrequency ablation therapeutic apparatus

Interventions

Multi-mode tumor treatment system DEVICE

The intervention for this arm involves the use of a novel multi-mode tumor treatment system, developed by Shanghai MAaGI Medical Technology Co., Ltd. The system combines cryoablation and radiofrequency ablation in a single device. During the treatment, the tumor tissue is rapidly frozen to create an ice ball larger than the lesion by 5mm, followed by thawing and rewarming. Subsequently, the lesion is treated with radiofrequency ablation according to conventional procedures to ensure complete ablation within a safety margin of 5-10mm around the tumor.

Also known as: MTT-P1

Multi-mode Ablation

Radiofrequency ablation therapeutic apparatus DEVICE

The intervention for this arm involves the use of conventional radiofrequency ablation equipment, which is developed by MedSphere International (Shanghai) Co., Ltd.. During the treatment, the tumor is ablated using predefined power and time settings to ensure complete ablation within a safety margin of 5-10mm around the tumor.

Also known as: S-1500

Conventional Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and 75 years, gender not specified;
• Pathologically confirmed primary liver cancer or colorectal cancer liver metastases, which is unresectable, intolerant to surgical resection, or refused surgical resection;
• Intrahepatic lesions with a diameter of ≤4cm, and the number of lesions ≤3.;
• At least 3 months since the last systemic treatment and at least 1 month since the last local treatment;
• Child-Pugh class A or B;
• ECOG PS ≤ 2.

You may not qualify if:

• Liver function Child-Pugh class C , severe jaundice, especially obstructive jaundice;
• Diffuse liver cancer, or with tumor thrombi in the main portal vein to secondary branches or hepatic vein;
• Significant liver atrophy, tumor volume too large, requiring ablation range of up to one-third of the liver volume;
• Multiple systemic metastases, expected survival \< 3 months;
• Recent history of esophageal (gastric fundus) variceal bleeding within the past month;
• Severe functional failure of major organs such as the liver, kidneys, heart, lungs or brain;
• Presence of active infection;
• Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a significant bleeding tendency;
• Refractory massive ascites, pleural effusion, or cachexia;
• Pregnancy, disorder or inability to cooperate with treatment;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Director of Interventional Therapy Department

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Therapy Department

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 12, 2022
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)