Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC

Laborértékek

• • 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.

• • 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.