Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC

Starting soon · Not applicable

Conditions studied: Unresectable Hepatocellular Carcinoma (HCC)

In brief

Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)

Key facts

Study ID

NCT07596134

Run by

Zhejiang University

People needed

166

Starts

2026-05-25

Expected to finish

2029-05-25

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • Invasion of the main portal vein;
• Diffuse hepatocellular carcinoma;
• 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.

Where it is running

• Huaihe Hospital of Henan University — Kaifeng, Henan, China
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang Provinece, China
• The Fourth Affiliated Hospital, Zhejiang University School of Medicine — Yiwu, Zhejiang Provinece, China

Full record on ClinicalTrials.gov

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