Liver Cancer (Primary and Metastatic)NCT07459309
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
A study testing Multimodal Tumor Thermal Ablation in people with Liver Cancer (Primary and Metastatic) and Liver Ablation, run by Fudan University at 1 site in China.
Trial summary
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer (Primary and Metastatic), Liver Ablation
- What is being tested?
- Multimodal Tumor Thermal Ablation
- 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
- 13 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, regardless of gender;
- Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer;
- Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm;
- Patient is intolerant to or refuses surgical resection;
- ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.
Who cannot join
- Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
- Massive or diffuse hepatocellular carcinoma;
- Presence of vascular tumor thrombus or invasion of adjacent organs;
- History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
- Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
- Refractory massive ascites, cachexia;
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- Active infection, especially inflammatory conditions of the biliary system;
- Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
- Impaired consciousness, or inability to cooperate with treatment;
- Previous systemic treatments (e.g., chemotherapy) with an interval of less than 2 weeks and not having recovered from prior treatment: CTCAE 6.0 grade >1 (except for alopecia);
- Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
wentao li, +86 13774225887, liwentao98@126.com
About this study
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
- Being tested
- Multimodal Tumor Thermal Ablation
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Tumor Thermal AblationDevice
Multimodal Tumor Thermal Ablation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Multimodal Tumor Thermal Ablation Receives: Device: Multimodal Tumor Thermal Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablation efficacy rate at 1 month postoperatively
Ablation efficacy rate at 1 month postoperatively
Measured: 1 month after ablation
Secondary outcomes (2)
Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment
Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment
Measured: 1 month after ablation
Adverse events and serious adverse events
Adverse events and serious adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start13 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer (Primary and Metastatic)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Tao Li, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459309
- Sponsor's protocol ID
- MTTIR-DHF-701
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
- ClinicalTrials.gov ID
- NCT07459309
- Acronym / sponsor ID
- MTTIR-DHF-701
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Mar 2026 (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.
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Multimodal Tumor Thermal AblationMultimodal Tumor Thermal Ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years, regardless of gender;
- Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer;
- Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm;
- Patient is intolerant to or refuses surgical resection;
- ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.
Key exclusion criteria (11 listed)
- Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
- Massive or diffuse hepatocellular carcinoma;
- Presence of vascular tumor thrombus or invasion of adjacent organs;
- History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
- Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
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 |
|---|---|---|
| Multimodal Tumor Thermal AblationMultimodal Tumor Thermal Ablation | Device | Treatment Group |
Primary outcome
Ablation efficacy rate at 1 month postoperatively
Time frame: 1 month after ablation
Ablation efficacy rate at 1 month postoperatively
2 secondary outcomes
Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment
Time frame: 1 month after ablation
Adverse events and serious adverse events
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Tumor Thermal Ablation in people with Liver Cancer (Primary and Metastatic) and Liver Ablation, 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 5 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wentao li (+86 13774225887, liwentao98@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablation efficacy rate at 1 month postoperatively (time frame: 1 month after ablation). 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 8 Jul 2026.