Freeze-and-Heat attack: could a new device boost liver cancer treatment?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.