Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant
NCT03966209 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-05-31
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
- DRUG
-
JS001(PD-1 inhibitor)
240mg I.V. Q3W
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-01
- Primary Completion
- 2021-04-30
- Completion
- 2022-10-31
Countries
- China
Study Locations
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