Hepatocellular CarcinomaNCT07159048
The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors
A study testing Multimodal Tumor Thermal Therapy System and Radiofrequency Ablation System or Microwave Ablation System in people with Hepatocellular Carcinoma and Colorectal Cancer Liver Metastasis, run by Fudan University at 1 site in China.
Trial summary
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Colorectal Cancer Liver Metastasis
- What is being tested?
- Multimodal Tumor Thermal Therapy System and Radiofrequency Ablation System or Microwave Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to 31 Oct 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 of 18-80 years.
- Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers.
- Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5.
- Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence.
- Child-Pugh score ≤7 (Class A or B).
- Performance status 0-1 (Eastern Cooperative Oncology Group classification).
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- Life expectancy of at least 3 months.
- Patients who have previously undergone surgery, chemotherapy, targeted therapy, ablation, vascular interventional therapy (TACE, D-TACE, HAIC), or immunotherapy, with an interval of ≥3 weeks since the last treatment.
- The functional level of major organs must meet the following requirements:
- Blood Routine: WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥50×109/L，HGB≥90 g/L. (2) Liver Function: AST ≤5.0×ULN, ALT ≤5.0×ULN, TBIL ≤2.0×ULN. (3) Renal Function: Cr ≤1.5×ULN or CrCl ≥60 mL/min. (4) Coagulation Function: INR ≤1.5; APTT ≤1.5×ULN. (5) HBV-DNA: HBV-DNA ≤2×10³ IU/mL (*Patients with HBV-DNA >2×10³ IU/mL may be enrolled but must receive antiviral therapy.*)
Who cannot join
- Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins.
- Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1/3 of the liver volume.
- Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding.
- Active bacterial infection or fungal infection.
- Previous or coexisting malignancies.
- History of solid organ transplant or hepatic encephalopathy.
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- Current enrollment in another clinical trial or prior exposure to experimental therapies.
- Pregnant or breastfeeding, or preparing to pregnant.
- Not suitable to participate in clinical trials judged by investigator.
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, Shanghai Municipality
Lichao Xu, M.D, +86-021-64175590, lichaoxu163@163.com
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. This prospective, multi-center, randomized controlled clinical study aimed to explore the ablation-induced immune activating response of MTT in the treatment of malignant liver tumors.
- Being tested
- Multimodal Tumor Thermal Therapy System, Radiofrequency Ablation System or Microwave Ablation System
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Tumor Thermal Therapy SystemDevice
All subjects were treated with a multi-modal thermal therapy system (Shanghai MAaGI Medical Technology Co., Ltd.) following a temperature-controlled tumor ablation protocol. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status.
Radiofrequency Ablation System or Microwave Ablation SystemDevice
All subjects were treated with a radiofrequency ablation system or microwave ablation System. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Tumor Thermal Therapy | Experimental | These patients will receive multimodal thermal therapy using multimodal tumor thermal therapy system. Receives: Device: Multimodal Tumor Thermal Therapy System |
| Single Thermal Ablation | Experimental | These patients will receive local ablation using the microwave ablation system or radiofrequency ablation system. Receives: Device: Radiofrequency Ablation System or Microwave Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS was defined as the time from the first ablation until local tumor progression, any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first).
Measured: At 12 months after the ablation procedure on Day 0
Assessment of immune activating response
The landscape of the peripheral immune response induced by local ablation in patients with malignant liver tumors.
Measured: In 6 months
Secondary outcomes (4)
Objective Response Rate（ORR）
Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Measured: At 6 months after the ablation procedure on Day 0
Local Control Rate（LCR）
LCR is defined as the proportion of patients demonstrating absence of disease progression at the ablated target site according to mRECIST criteria, as evaluated by diagnostic imaging, without evidence of progressive disease (PD) within the prescribed follow-up period.
Measured: At 6 months after the ablation procedure on Day 0
Overall Survival (OS)
OS refers to the time from the date of enrollment to the date of death due to any cause.
Measured: At 36 months after the ablation procedure on Day 0
Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation
Percentage of participants with AEs within 3 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device.
Measured: From time of first ablation (Day 0) up to 3 months post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Lichao Xu, Fudan University
- Investigators
- Lichao Xu, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159048
- Sponsor's protocol ID
- 2025-308-4457
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2025
- Last updated
- 10 Aug 2026
- Results posted
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors
- ClinicalTrials.gov ID
- NCT07159048
- Acronym / sponsor ID
- 2025-308-4457
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Ruijin Hospital
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 8 Sep 2025 (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.
Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. This prospective, multi-center, randomized controlled clinical study aimed to explore the ablation-induced immune activating response of MTT in the treatment of malignant liver tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Tumor Thermal Therapy | Experimental | Device: Multimodal Tumor Thermal Therapy SystemThese patients will receive multimodal thermal therapy using multimodal tumor thermal therapy system. |
| Single Thermal Ablation | Experimental | Device: Radiofrequency Ablation System or Microwave Ablation SystemThese patients will receive local ablation using the microwave ablation system or radiofrequency ablation system. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age of 18-80 years.
- Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers.
- Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5.
- Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence.
- Child-Pugh score ≤7 (Class A or B).
Key exclusion criteria (9 listed)
- Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins.
- Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1/3 of the liver volume.
- Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding.
- Active bacterial infection or fungal infection.
- Previous or coexisting malignancies.
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 Therapy SystemAll subjects were treated with a multi-modal thermal therapy system (Shanghai MAaGI Medical Technology Co., Ltd.) following a temperature-controlled tumor ablation protocol. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status. | Device | Multimodal Tumor Thermal Therapy |
| Radiofrequency Ablation System or Microwave Ablation SystemAll subjects were treated with a radiofrequency ablation system or microwave ablation System. Complete ablation of intrahepatic lesions was achieved, resulting in no evidence of disease (NED) within the liver. For lesions that could not be fully ablated in a single session, two treatment sessions were performed to attain intrahepatic NED status. | Device | Single Thermal Ablation |
Primary outcome
Progression Free Survival (PFS)
Time frame: At 12 months after the ablation procedure on Day 0
PFS was defined as the time from the first ablation until local tumor progression, any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first).
Assessment of immune activating response
Time frame: In 6 months
The landscape of the peripheral immune response induced by local ablation in patients with malignant liver tumors.
4 secondary outcomes
Objective Response Rate（ORR）
Time frame: At 6 months after the ablation procedure on Day 0
Local Control Rate（LCR）
Time frame: At 6 months after the ablation procedure on Day 0
Overall Survival (OS)
Time frame: At 36 months after the ablation procedure on Day 0
Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation
Time frame: From time of first ablation (Day 0) up to 3 months post ablation
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 10 Aug 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.
Lichao Xu, M.D 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 Multimodal Tumor Thermal Therapy System and Radiofrequency Ablation System or Microwave Ablation System in people with Hepatocellular Carcinoma and Colorectal Cancer Liver Metastasis, 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 10 inclusion and 9 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 10 Aug 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 Lichao Xu, M.D (: +86-021-64175590, lichaoxu163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: At 12 months after the ablation procedure on Day 0). 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 10 Aug 2026.