NCT05322187

Sequential PD-1/PD-L1 Inhibitor and LENvatinib in TLCT and Refractory Hepatoblastoma After Chemotherapy

Sequential PD-1/PD-L1 Inhibitor and LENvatinib in Transitional Liver Cell Tumors（TLCT）and Refractory Hepatoblastoma for Young Adolescent and Pediatric Participants After Chemotherapy：a Cohort Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label trial studying the combination of PD-1/PD-L1 Inhibitor (e.g.pembrolizumab, Sintilimab,Duvarizumab，Camrelizumab )and lenvatinib given at the recommended dose in pediatric and young adolescent patients((5 year-old\<age\<14 year-old) with TLCT or refractory hepatoblastoma after chemotherapy.

Detailed description

Transitional liver cell tumors exhibit an unusual phenotype with respect to clinical presentation, histopathology, immunohistochemistry, and treatment response. These apparently novel, unusual, and aggressive tumors occurring in older children and adolescents may form a transition in the putative developmental pathway of hepatocarcinogenesis, and usually refractory, resistant to chemotherapy. The sPLENTY-pc is a perspective cohort study, investigating the efficiency of sequential combined usage of PD-1 Inhibitor (e.g.pembrolizumab, Sintilimab,Camrelizumab ) or PD-L1 inhibitor (Duvarizumab) plus lenvatinib given at the recommended dose in pediatric \>5 year-old and young adult patients\<14 yo with TLCT or refractory hepatoblastoma after chemotherapy.

Conditions

• Transitional Cell Tumor
• Hepatoblastoma
• Liver Cancer
• Pediatric Solid Tumor
• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	Sequential PD-1/PD-L1 Inhibitor and LENvatinib treatment after chemotherapy resistance

Timeline

• Start date: 2022-04-10
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

1 site across 1 country: China