A Phase 2/3 interventional study of PD-1 inhibitor in Transitional Cell Tumor, Hepatoblastoma and Liver Cancer, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by RenJi Hospital · Phase 2/3, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 15 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
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Exclusion Criteria:
Treatment of PD-1/PD-L1 Inhibitor and LENvatinib would be employed in PLEN
Drug: PD-1 inhibitor
Sequential PD-1/PD-L1 Inhibitor and LENvatinib treatment after chemotherapy resistance
Also known as: PD-L1 inhibitor, lenvatinib, Camrelizumab, Pembrolizumab, Duvarizumab, Sintilimab
Objective response rate (complete response/partial response)
Determined using Response Evaluation Criteria in Solid Tumors version 1.1. A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
Time frame: up to 1 year
dynamic α-fetoprotein response (AFP-R)
The AFP-R was measured as the difference between maximum and final pre-liver transplant/resection AFP level, if surgery is not possible, the final level of AFP would be measured as the AFP at 6 month.
Time frame: up to 6 months for unresectable.
Incidence and severity of study treatment-related adverse events measured by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5
oxicities will be defined using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.
Time frame: up to 12 months
Health outcomes as assessed by the PROMIS® Pediatric Scale v1.0 Global Health 7+2 scores at baseline, prior to start of each cycle, and last trial visit
Each question will be rated from the following: Excellent (5) to Poor (1), Never (5) to Always (1), or Never (1) to Almost Always (5)
Time frame: up to 12 months
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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RenJi Hospital