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

NCT ID: NCT05322187

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-10
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLEN(PD-1/PD-L1 inhibitor and LENvatinib)

Treatment of PD-1/PD-L1 Inhibitor and LENvatinib would be employed in PLEN

Group Type: EXPERIMENTAL

PD-1 inhibitor

Intervention Type: DRUG

Sequential PD-1/PD-L1 Inhibitor and LENvatinib treatment after chemotherapy resistance

Interventions

PD-1 inhibitor

Sequential PD-1/PD-L1 Inhibitor and LENvatinib treatment after chemotherapy resistance

Intervention Type: DRUG

Other Intervention Names

PD-L1 inhibitor; lenvatinib; Camrelizumab; Pembrolizumab; Duvarizumab; Sintilimab

Eligibility Criteria

Inclusion Criteria

• Patients must be >= than 5 years and =< 14 years of age at the time of study enrollment
• pathological diagnosis of TLCT/NOS, or hepatoblastoma（HB）（Emergent Treatment for HB In emergency situation when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.）
• Failed prior first-line or second-line chemotherapy
• general charactoristics: Lansky performance status 50-100% in patients ≤ 10 years of age OR Karnofsky performance status 50-100% in patients > 10 years of age Life expectancy > 8 weeks Hemoglobin > 8 g/dL Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Total bilirubin ≤ 5 x upper limit of normal (ULN) for age, Aspartate aminotransferase (AST) or Alanine transaminase (ALT) < 10 x upper limit of normal (ULN) for age. Serum creatinine ≤ 3 times normal Normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate) Not pregnant or nursing No severe uncontrolled infection or enterocolitis
• Recovered from toxicity of prior therapy No chemotherapy within 3 weeks prior to study entry No prior PD1/PD-L1 blockade treatment

• Patients who are currently receiving another investigational drug.
• Patients who are currently receiving other anticancer agents.
• Patients with uncontrolled infection.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of PD1/PD-L1 blockade

Exclusion Criteria

• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Feng

Role: PRINCIPAL_INVESTIGATOR

Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

Qiang Xia

Role: STUDY_CHAIR

Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

Locations

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Countries

China

Central Contacts

Hao Feng

Role: CONTACT

surgeonfeng@live.com

008615000901110

Qiang Xia

Role: CONTACT

Other Identifiers

RenJi-IIT2022-241

Identifier Type: -

Identifier Source: org_study_id