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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Month Progression-Free Survival | 6-month progression-free survival (6-month PFS) refers to the percentage of patients who are alive without tumor progression or metastasis six months after the start of treatment. | 6 months |
| 1-Year Progression-Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director of Interventional Therapy Department | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China |
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| 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. |
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1-year progression-free survival (1-year PFS) refers to the percentage of patients who are alive without tumor progression or metastasis one year after the start of treatment. |
| 1 year |
| 1-Year Overall Survival | 1-year overall survival (1-year OS) refers to the percentage of patients who are still alive one year after the start of treatment. | 1 year |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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