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 (irinotecan hydrochloride injection): * Irinotecan hydrochloride injection: 50 mg/m², administered by intravenous infusion once daily on Days 1-5. * Each 3 weeks constitutes one cycle. For patients who discontinue the study drug without radiological progression, follow-up and tumor assessment will continue until progressive disease (PD) occurs, new anti-tumor therapy is initiated, or death. * Tumor tissues and peripheral blood of patients will be collected for relevant tests.
Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L;
Platelet count ≥100×10⁹/L;
Total bilirubin ≤1.5×Upper Limit of Normal (ULN);
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5×ULN (for participants with liver metastases, ALT or AST ≤5×ULN is allowed);
Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies);
Active tuberculosis;
Other uncontrolled active infections (CTCAE V5.0 >Grade 2); Failure to recover from surgery, such as unhealed incisions or severe postoperative complications; Vaccination with any live-attenuated vaccine within 4 weeks before enrollment or likely to be administered during the study period; seasonal influenza vaccines without live viruses are allowed.
Single group
Pucotenlimab ,Lenvatinib
DrugA total of 24 cases are planned to be enrolled. All subjects will receive Pucotenlimab (3mg/kg, on Day 1, with a maximum dose not exceeding 200mg) once every 3 weeks (Q3W), in combination with Lenvatinib and Irinotecan. The chemotherapy regimen is fixed: Lenvatinib capsules 7mg/m2 (maximum 12mg) orally from Day 1 to 21 and Irinotecan 50mg/m2 from Day 1 to 5. Chemotherapy will be administered for 2 to 4 cycles, once every 3 weeks (Q3W).
PFS
progression of the disease or the death
OS
Overall survival (OS) is defined as the time from the initiation of treatment with pucotenlimab in combination with theLenvatinib and Irinotecan regimen until the patient's death from any cause. Death is determined based on official medical records or other reliable documentation. The follow - up for OS will continue throughout this estimated assessment period.
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