NCT03966209

Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant

Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a perspective clinical study to assess the safety and efficacy of PD-1 inhibitors in patients with LT. Eligible patients have recurrent or metastatic cancer after LT, are not amenable to, or refractory after, locoregional therapy or to a curative treatment approach (eg, surgery, or ablation) and have previously been treated with sorafenib or other targeted therapy, either intolerant to this treatment or show radiographic progression after treatment. Biopsy is needed to exclude patients with positive allograft PD-L1 expression.

Conditions

• Hepatocellular Carcinoma
• Liver Transplantation

Interventions

Type	Name	Description
DRUG	JS001(PD-1 inhibitor)	240mg I.V. Q3W

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-04-30
• Completion: 2022-10-31
• First posted: 2019-05-29
• Last updated: 2019-05-31

Locations

1 site across 1 country: China