Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relap
This study is a single-cohort study. Pediatric patients with advanced, relapsed/refractory hepatoblastoma who have previously failed first-line or higher systemic therapy will receive 2 cycles of treatment with sintilimab combined with lenvatinib and chemotherapy (irinotecan). Patients may discontinue treatment due to
| Condition(s) | Hepatoblastoma, Pediatric Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study is a single-cohort study. Pediatric patients with advanced, relapsed/refractory hepatoblastoma who have previously failed first-line or higher systemic therapy will receive 2 cycles of treatment with sintilimab combined with lenvatinib and chemotherapy (irinotecan). Patients may discontinue treatment due to disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or other reasons specified in the protocol, whichever occurs first. * Dose setting: * Sintilimab: The recommended dose is 3 mg/kg (maximum dose not exceeding 200 mg per administration), administered by intravenous infusion (60±15 minutes) once daily on Day 1. * Lenvatinib: 7 mg/m² (maximum 12 mg), taken orally once daily on Days 1-21. * Chemotherapy (irinote |
| Who can participate | Voluntarily enroll in the study and sign a written informed consent form; Aged 2-18 years, with no gender restrictions; Patients with histologically or cytologically confirmed locally advanced or metastatic hepatoblastoma who have received at least 1 line of systemic therapy. Participants must have experienced disease progression after previous treatment, or have relapsed or refractory disease (failure to achieve complete remission or partial remission after at least 2 courses of first-line treatment); According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one radiologically measurable lesion. Lesions within the field of previous radiotherapy can be considered measurable if progression is confirmed; or there is "non-measurable disease" associated wit |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Lead sponsor | Sun Yat-sen University |
| Locations | Guangdong, Guangzhou, China |
| Start date | 2025-04-10 |
| NCT ID | NCT07188311 |
| Official listing | https://clinicaltrials.gov/study/NCT07188311 |