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Trial Title:
Multi-mode Ablation and Molecular Imaging Multi-omics Study for Digestive-Origin Malignant Liver Tumors
NCT ID:
NCT06588569
Condition:
Primary Liver Cancer
Colorectal Cancer Liver Metastases
Conditions: Official terms:
Liver Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multi-mode tumor treatment system
Description:
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.
Arm group label:
Multi-mode Ablation
Other name:
MTT-P1
Intervention type:
Device
Intervention name:
Radiofrequency ablation therapeutic apparatus
Description:
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.
Arm group label:
Conventional Radiofrequency Ablation
Other name:
S-1500
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Start date:
October 12, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06588569
