Unresectable hepatocellular carcinoma
Conditions
Interventions
Experimental group:Multimodal Thermal Therapy Combined with Targeted and Immune Drugs
Control Group:Targeted and Immune Drugs
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-80 years old, gender not restricted; 2. Diagnosed as non-surgically resectable HCC through imaging or histological methods, with BCLC stage B or C; 3. Not receiving systemic drug treatments such as systemic immunotherapy, chemotherapy, or targeted therapy for HCC; 4. Has an evaluable imaging-based lesion that has not undergone local ablation treatment, and the maximum diameter of the lesion to be ablated is <= 5 cm; 5. Child-Pugh score <= 7 points; 6. ECOG-PS score is 0 to 1 point.
Exclusion criteria
Exclusion criteria: 1. Infringement of the main trunk of the portal vein; 2. Diffuse liver cancer; 3. Those who have been diagnosed with brain metastasis in the past or currently, and whose symptoms have not been completely controlled (i.e., symptoms persist, worsen, or require adjustment of the symptomatic treatment plan to maintain symptom relief); 4. Extensive distant metastasis diagnosed by imaging examinations (such as chest and abdominal CT/MRI, whole-body bone scan, PET-CT, etc.), including but not limited to diffuse lung metastasis, multiple bone metastases, extensive abdominal cavity/peritoneal metastasis, or other multi-organ metastases, as assessed by the investigator, the extent of metastasis may lead to the inability to safely implement the study treatment or affect the efficacy and safety assessment; 5. Those who have received local treatment in the past and the interval between the last local treatment is less than 4 weeks; 6. Complicated with invasion of major blood vessels such as hepatic veins, inferior vena cava, etc.; 7. Uncontrolled active infection; 8. Renal dysfunction, serum creatinine > 176.8 µmol/L or creatinine clearance rate 18 seconds, prothrombin activity = 10 mg/day equivalent of prednisone), or those who are currently using other immunosuppressive drugs (such as cyclosporine, tacrolimus, methotrexate, etc.) for treatment; those who use topical, inhalation or ophthalmic glucocorticoids and do not affect the systemic immune function, and can be considered for enrollment after assessment by the investigator; 13. Past or current diagnosis of other malignant tumors other than the target tumor of this study (excluding low-grade malignant tumors such as skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, etc.). For low-grade malignant tumors, the decision on whether to enroll is to be made by the investigator after assessment; 14. Pregnant or lactating women, or women of childbearing age who have a pregnancy plan during the study treatment and within 3 months after the end of the treatment; 15. Estimated survival period < 3 months; 16. Researchers consider that they are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in immune indicators;Safety;Visual Analogue Scale (VAS) Score;Objective Response Rate (ORR);Disease Control Rate (DCR);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactTingbo Liang
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed