New combo therapy aims to freeze and burn liver cancer
NCT ID NCT07159048
First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 4 times
Summary
This study tests a device that uses both freezing and heating to destroy liver tumors in people with liver cancer or colorectal cancer that has spread to the liver. The goal is to see if this approach improves how long patients live without their cancer growing, and whether it activates the immune system. About 120 adults will take part across multiple hospitals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Multimodal Tumor Thermal Therapy System (device combining cryotherapy and radiofrequency heating)
- What this could lead to
- If successful, this approach could offer a more effective way to destroy liver tumors and potentially boost the body's immune response against cancer.
- What could go wrong
- This is an early-stage trial with only 120 participants, so results may not apply to everyone. The therapy is complex and may not work better than standard ablation methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age of 18-80 years. 2. Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers. 3. Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5. 4. Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence. 5. Child-Pugh score ≤7 (Class A or B). 6. Performance status 0-1 (Eastern Cooperative Oncology Group classification). 7. Life expectancy of at least 3 months. 8. 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. 9. The functional level of major organs must meet the following requirements: (1) 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.\*) Exclusion Criteria: 1. Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins. 2. Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1/3 of the liver volume. 3. Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding. 4. Active bacterial infection or fungal infection. 5. Previous or coexisting malignancies. 6. History of solid organ transplant or hepatic encephalopathy. 7. Current enrollment in another clinical trial or prior exposure to experimental therapies. 8. Pregnant or breastfeeding, or preparing to pregnant. 9. Not suitable to participate in clinical trials judged by investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
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- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial
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