Status:
ACTIVE_NOT_RECRUITING
Multi-mode Ablation and Molecular Imaging Multi-omics Study for Digestive-Origin Malignant Liver Tumors
Lead Sponsor:
Fudan University
Conditions:
Primary Liver Cancer
Colorectal Cancer Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
NA
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 safe...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Any other factors deemed inappropriate for inclusion or affecting the subject's participation in the study, as determined by the investigators.
Key Trial Info
Start Date :
October 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06588569
Start Date
October 12 2022
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China