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NCT07596134

Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC

Sponsor: Zhejiang University

View on ClinicalTrials.gov

Summary

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2026-05-25

Completion Date

2029-05-25

Last Updated

2026-05-22

Healthy Volunteers

Conditions

Unresectable Hepatocellular Carcinoma (HCC)

Interventions

DEVICE

Multimodal Thermal Therapy

Multimodal Thermal Therapy (MTT) is an advanced ablation technique that utilizes an integrated microprobe to combine liquid nitrogen freezing with radiofrequency heating. This dual-action process creates a rapidly shifting temperature field and significant tissue stress, leading to the complete destruction of tumor cells and their associated blood vessels. Beyond local tumor removal, the procedure acts as an "in situ vaccine" by releasing tumor-associated antigens and danger signals into the bloodstream, which activates a systemic and durable anti-tumor immune response.

DRUG

Targeted and Immune Drugs

In this research, systemic treatment specifically refers to the combination of targeted therapies and immune checkpoint inhibitors, such as PD-1 inhibitors. These drugs are selected based on their approval by the NMPA for liver cancer treatment and the specific clinical needs of the patient. The primary role of the immune drugs is to block immune checkpoints, which prevents the tumor from escaping the body's defenses and significantly enhances the natural anti-tumor function of T cells. Complementing this, the targeted drugs-often anti-angiogenic agents-work to inhibit tumor blood vessel growth and improve the overall immune microenvironment. When used together, they create a synergistic "dual" effect: the targeted drugs optimize the environment for immune cell infiltration while the immune drugs activate T cells to more effectively attack the cancer.

Inclusion Criteria: * • 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. Exclusion Criteria: * • 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.

Locations (4)

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