Primary Liver CancerNCT06588569
Multi-mode Ablation and Molecular Imaging Multi-omics Study for Digestive-Origin Malignant Liver Tumors
A study testing Multi-mode tumor treatment system and Radiofrequency ablation therapeutic apparatus in people with Primary Liver Cancer and Colorectal Cancer Liver Metastases, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Liver Cancer, Colorectal Cancer Liver Metastases
- What is being tested?
- Multi-mode tumor treatment system and Radiofrequency ablation therapeutic apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction of a Multi-mode Ablation Treatment System and Molecular Imaging Multi-omics Study for Malignant Liver Tumors of Digestive System Origin
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.
Read the 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.
- Being tested
- Multi-mode tumor treatment system, Radiofrequency ablation therapeutic apparatus
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-mode tumor treatment systemDevice
Also called MTT-P1
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.
Radiofrequency ablation therapeutic apparatusDevice
Also called S-1500
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Radiofrequency ablation therapeutic apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
1-Year Progression-Free Survival
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Oct 2022
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Tao Li, Fudan University
- Investigators
- Director of Interventional Therapy Department, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588569
- Sponsor's protocol ID
- IR20210728
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Multi-mode Ablation Treatment System and Molecular Imaging Multi-omics Study for Malignant Liver Tumors of Digestive System Origin
- ClinicalTrials.gov ID
- NCT06588569
- Acronym / sponsor ID
- IR20210728
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-mode Ablation | Experimental | Device: Multi-mode tumor treatment systemThis 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. |
| Conventional Radiofrequency Ablation | Active comparator | Device: Radiofrequency ablation therapeutic apparatusThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-mode tumor treatment systemAlso: MTT-P1The 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. | Device | Multi-mode Ablation |
| Radiofrequency ablation therapeutic apparatusAlso: S-1500The 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. | Device | Conventional Radiofrequency Ablation |
Primary outcome
Antitumor immune response
Time frame: max 24 months
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.
6-month Disease Control Rate
Time frame: 6 months
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.
3 secondary outcomes
6-Month Progression-Free Survival
Time frame: 6 months
1-Year Progression-Free Survival
Time frame: 1 year
1-Year Overall Survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director of Interventional Therapy Department principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-mode tumor treatment system and Radiofrequency ablation therapeutic apparatus in people with Primary Liver Cancer and Colorectal Cancer Liver Metastases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antitumor immune response (time frame: max 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.