ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two
| Condition(s) | HCC - Hepatocellular Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants throug |
| Who can participate | Inclusion Criteria: 1. Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up. 2. Age ≥18 years at the time of signing informed consent, regardless of gender. 3. Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology. 4. BCLC Stage B or C. 5. At least one measurable lesion per RECIST 1.1. 6. ECOG score of 0-1. 7. Child-Pugh liver function class A or B. 8. Life expectancy ≥ 3 months. 9. Adequate hematological and organ function. Exclusion Criteria: 1. Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver trans |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Peking Union Medical College Hospital |
| Locations | Beijing, China |
| Start date | 2025-02-19 |
| NCT ID | NCT07157969 |
| Official listing | https://clinicaltrials.gov/study/NCT07157969 |