Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAI
This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
| Condition(s) | Hepatocellular Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma |
| Who can participate | Inclusion Criteria: 1. The written informed consent form should be signed before a subject participates in the trial； 2. Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by the American Association for the Study of Liver Diseases (AASLD)； 3. According to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition), eligible for China liver cancer staging (CNLC) Stage IIIa and is not suitable for radical treatment, such as resection, ablation, or liver transplantation. Suitable for HAIC surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications to HAIC surgery and chemotherapy drugs； 4. Child-Pugh A or B； 5. at least 1 measurable lesion according to RECIST v1.1 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Hunan Cancer Hospital |
| Locations | Changsha, Hunan, China |
| Start date | 2024-05-15 |
| NCT ID | NCT06406634 |
| Official listing | https://clinicaltrials.gov/study/NCT06406634 |