NCT04035876

Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant

A Single Group, Open Label, Multi-center Clinical Study of Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of Hepatocellular Cancer Before Liver Transplant

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.

Detailed description

HCC patients waiting for liver transplantation will be screened and enrolled according to the inclusion criteria. After screening and enrollment, patients will be administrated camrelizumab 200mg q2w iv and apatinib 250mg qd po regimen every 4 weeks as a cycle. Each patient will receive camrelizumab treatment for at least 2 cycles and discontinue camrelizumab 5 weeks before liver transplantation. Apatinib will be discontinued 1 week before liver transplantation. Once the tumor progression was detected, the program will be terminated and the appropriate optimal treatment will be given. The objective remission rate (ORR), recurrence-free survival (RFS), overall survival (OS), time to progress (TTP) and any adverse effect during the study will be evaluated in order to assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.

Conditions

• Hepatocellular Carcinoma
• Liver Transplant

Interventions

Type	Name	Description
DRUG	Camrelizumab plus apatinib	Camrelizumab 200mg q2w iv and apatinib 250mg qd po.

Timeline

• Start date: 2019-07-16
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-07-29
• Last updated: 2019-07-29

Locations

1 site across 1 country: China