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Sequential PD-1/PD-L1 Inhibitor and LENvatinib in TLCT and Refractory Hepatoblastoma After Chemotherapy (sPLENTY-pc)

Primary Purpose

Transitional Cell Tumor, Hepatoblastoma, Liver Cancer

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PD-1 inhibitor

About this trial

This is an interventional treatment trial for Transitional Cell Tumor

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

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.
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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)

Full Information

NCT ID

NCT05322187

First Posted

April 3, 2022

Last Updated

April 3, 2022

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05322187

Brief Title

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

Acronym

sPLENTY-pc

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 10, 2022 (Anticipated)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PD-1 inhibitor

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate (complete response/partial response)

Description

Time Frame

up to 1 year

Title

dynamic α-fetoprotein response (AFP-R)

Description

Time Frame

up to 6 months for unresectable.

Secondary Outcome Measure Information:

Title

Incidence and severity of study treatment-related adverse events measured by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5

Description

oxicities will be defined using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.

Time Frame

up to 12 months

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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 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. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hao Feng

Phone

008615000901110

surgeonfeng@live.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qiang Xia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao Feng

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qiang Xia

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Shanghai

ZIP/Postal Code

200127

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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