NCT07596134Not yet recruiting
Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC
Multimodal Thermal Therapy With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone for Systemically Untreated Unresectable (HCC): a Prospective, Multicenter, Open-label, Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 2 May 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Zhejiang University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07596134
What you commit to
- Study type: Interventional
- Planned participants: 166
- From Oct 2026 to the primary completion date, Oct 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • Invasion of the main portal vein;
- Diffuse hepatocellular carcinoma;
- The hepatic lesion occupies more than 50% of the liver volume.
- Patients with a history or current diagnosis of brain metastases whose symptoms are not fully controlled (i.e., persistent or worsening symptoms, or requiring adjustments to symptomatic treatment to maintain symptom relief);
- Extensive distant metastasis confirmed by imaging (e.g., chest/abdominal CT/MRI, whole-body bone scan, PET-CT, etc.), including but not limited to diffuse lung metastasis, multiple bone metastases, extensive abdominal/peritoneal metastasis, or other multi-organ metastases, where the investigator assesses that the extent of metastasis may compromise the safe administration of study treatment or affect efficacy and safety evaluations;
- Prior local therapy with the last treatment administered less than 4 weeks before enrollment;
- Involvement of major blood vessels such as the hepatic vein or inferior vena cava;
- Uncontrolled active infection;
- Renal dysfunction with serum creatinine \>176.8 μmol/L or creatinine clearance \<30 mL/min;
- Uncorrectable coagulation abnormalities: platelets \<50×10⁹/L, prothrombin time \>18 seconds, prothrombin activity \<40%, and uncorrectable;
- History of esophageal or gastric variceal bleeding without effective treatment via endoscopy, intervention, or surgery;
- Patients with active psychiatric disorders;
- Patients receiving or requiring systemic glucocorticoids (e.g., prednisone, dexamethasone) at a dose ≥10 mg/day (prednisone equivalent) or other immunosuppressive drugs (e.g., cyclosporine, tacrolimus, methotrexate) within 14 days prior to enrollment; topical, inhaled, or ophthalmic glucocorticoid use that does not affect systemic immune function may be allowed at the investigator's discretion;
- History or current diagnosis of malignancies other than the target tumor in this study (excluding cured low-grade malignancies such as basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ). For low-grade malignancies, eligibility will be determined by the investigator;
- Pregnant or breastfeeding women, or women of childbearing potential planning pregnancy during the study or within 3 months after treatment completion;
- Expected survival \<3 months;
- Patients deemed unsuitable for participation by the investigator.
Who the study is looking for
- • Age 18-80, regardless of gender;
- Diagnosed with unresectable HCC by imaging or histology, BCLC stage B or C;
- No prior systemic immunotherapy, chemotherapy, targeted therapy, or other systemic drug treatments for HCC;
- Presence of an image-evaluable lesion intended for ablation without prior local ablation therapy, with the maximum diameter of the target tumor ≤5 cm;
- Child-Pugh score ≤7;
- ECOG-PS score of 0-1.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Division Hospital of Xinjiang Production and Construction Corps Coordinator of this site? Confirm its status | Aksu | China | Unknown status |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Hospital Of Jiaxing Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Huaihe Hospital of Henan University Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.