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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\
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLEN(PD-1/PD-L1 inhibitor and LENvatinib) | Experimental | Treatment of PD-1/PD-L1 Inhibitor and LENvatinib would be employed in PLEN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor | Drug | Sequential PD-1/PD-L1 Inhibitor and LENvatinib treatment after chemotherapy resistance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to 6 months for unresectable. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Feng | Contact | 008615000901110 | surgeonfeng@live.com | |
| Qiang Xia | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Hao Feng | Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU | Principal Investigator |
| Qiang Xia | Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D018197 | Hepatoblastoma |
| D008113 | Liver Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| C531958 | lenvatinib |
| C000631724 | camrelizumab |
| C582435 | pembrolizumab |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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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) |
| up to 12 months |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |