Status:
UNKNOWN
Sequential PD-1/PD-L1 Inhibitor and LENvatinib in TLCT and Refractory Hepatoblastoma After Chemotherapy
Lead Sponsor:
RenJi Hospital
Conditions:
Transitional Cell Tumor
Hepatoblastoma
Eligibility:
All Genders
5-14 years
Phase:
PHASE2
PHASE3
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 pediatr...
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 ag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05322187
Start Date
April 10 2022
End Date
December 31 2023
Last Update
April 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200127