Clinical trial NCT06588569: Multi-mode Ablation and Molecular Imaging Multi-omics Study for Digestive-Origin Malignant Liver Tumors
Official title: Construction of a Multi-mode Ablation Treatment System and Molecular Imaging Multi-omics Study for Malignant Liver Tumors of Digestive System Origin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Liver Cancer
Colorectal Cancer Liver Metastases
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a single-center, parallel-controlled clinical trial. The study includes a total enrollment of 20 subjects. 10 patients with primary liver cancer will be divided into an experimental group and a control group (5 cases per group); 10 patients with Colorectal Cancer Liver Metastases will also be divided into the experimental group and the control group (5 cases per group). The purpose is to validate the safety and efficacy of multi-mode tumor ablation for liver malignant tumors, aiming to establish a multi-mode tumor treatment system and obtain multi-dimensional biomedical information from patients before, during and after ablation.

The study will employ an interdisciplinary approach, integrating statistics, machine learning and artificial intelligence, to establish a new technical system for rapid efficacy evaluation. Additionally, it will establish a multi-omics artificial intelligence-assisted diagnostic and evaluation system based on radiomics. The system will use artificial intelligence algorithms to automatically locate and identify lesions based on imaging guidance information and accurately predict individual prognoses and anti-tumor immune states through comprehensive preoperative, intraoperative, and postoperative evaluations, providing an important basis for treatment planning, intraoperative dose adjustment, and subsequent treatment strategies.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Liver function Child-Pugh class C , severe jaundice, especially obstructive jaundice;
2. Diffuse liver cancer, or with tumor thrombi in the main portal vein to secondary branches or hepatic vein;
3. Significant liver atrophy, tumor volume too large, requiring ablation range of up to one-third of the liver volume;
4. Multiple systemic metastases, expected survival \< 3 months;
5. Recent history of esophageal (gastric fundus) variceal bleeding within the past month;
6. Severe functional failure of major organs such as the liver, kidneys, heart, lungs or brain;
7. Presence of active infection;
8. Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a significant bleeding tendency;
9. Refractory massive ascites, pleural effusion, or cachexia;
10. Pregnancy, disorder or inability to cooperate with treatment;
11. Any other factors deemed inappropriate for inclusion or affecting the subject's participation in the study, as determined by the investigators.

Primary outcomes:
measure: Antitumor immune response
timeFrame: max 24 months
measure: 6-month Disease Control Rate
timeFrame: 6 months
Secondary outcomes:
measure: 6-Month Progression-Free Survival
timeFrame: 6 months
measure: 1-Year Progression-Free Survival
timeFrame: 1 year
measure: 1-Year Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Director of Interventional Therapy Department
role: PRINCIPAL_INVESTIGATOR
References: