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

NCT05322187 | Unknown Phase 2

• 1 other identifier: RenJi-IIT2022-241
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• Incidence and severity of study treatment-related adverse events measured by 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

  up to 12 months

Study Arms (1)

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

EXPERIMENTAL

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

Drug: PD-1 inhibitor

Interventions

PD-1 inhibitor DRUG

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

Also known as: PD-L1 inhibitor, lenvatinib, Camrelizumab, Pembrolizumab, Duvarizumab, Sintilimab

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

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Hepatoblastoma; Liver Neoplasms; Neoplasms

Interventions

Immune Checkpoint Inhibitors; lenvatinib; camrelizumab; pembrolizumab; sintilimab

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• 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

Central Study Contacts

Hao Feng

CONTACT

008615000901110; surgeonfeng@live.com

Qiang Xia

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 11, 2022
• Study Start: April 10, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-03

Locations

CN (1)