Phase 2 Study of WGI-0301 for Advanced HCC
The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.
| Condition(s) | Advanced Hepatocellular Carcinoma (HCC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors. |
| Who can participate | Inclusion Criteria: 1. ≥18 years of age on the day of signing informed consent, male or female. 2. Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol. 3. Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per 2018 AASLD criteria. 4. BCLC Stage C or BCLC Stage B with bilobar involvement and infiltrative nature that is only suitable for systemic anti-tumor therapy, and not suitable for any curative surgeries, liver transplantation, or local therapy (BCLC Classification see Appendix 6, Section 14.6). 5. Stage 1 only: At least first-line standard treatment failure (disease progression confirmed by imaging) with no available standard treatment options, or unsuitability for standard tre |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Zhejiang Haichang Biotech Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China; Chengdu, China; Hangzhou, China; Hong Kong, Hong Kong |
| Start date | 2024-07-31 |
| NCT ID | NCT06309485 |
| Official listing | https://clinicaltrials.gov/study/NCT06309485 |