Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma
This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Based on different patterns of disease progression, patients will receive relevant systemic treatments
| Condition(s) | Hepatocellular Carcinoma(HCC) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Based on different patterns of disease progression, patients will receive relevant systemic treatments, either with or without local interventional therapy. The primary endpoint is progression-free survival (PFS), while secondary endpoints include overall survival (OS), 1-year OS rate, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and safety. Additionally, the study will explore the correlation between patients' clinical pathological characteristics, serum biomarkers, and clinical efficacy. |
| Who can participate | Inclusion Criteria: 1. Age ≥18 years old, male or female 2. Hepatocellular carcinoma patients diagnosed by cytology or tissue puncture, or who meet clinical diagnostic criteria and cannot be treated with radical treatment (radical surgery, ablation, radiotherapy, etc.) 3. Disease progression after first-line targeted combined immune system therapy (as per RECIST1.1 criteria) 4. Life expectancy exceeds 3 months 5. ECOG physical condition score 0\~1 6. Women of childbearing age must have a serum pregnancy study done within 7 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must consent to contraception within 24 weeks from the date of signing the informed consent to the last admini |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Nanjing Tianyinshan Hospital |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2025-05-22 |
| NCT ID | NCT06893887 |
| Official listing | https://clinicaltrials.gov/study/NCT06893887 |