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

Primary Purpose

Hepatocellular Carcinoma, Liver Transplantation

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JS001(PD-1 inhibitor)
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Checkpoint Inhibitor, Immunotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with recurrence or metastases Hepatocellular carcinoma after liver transplantation that not suitable for surgical resection and Local treatments such as radiofrequency ablation, transcatheter arterial embolization and radiotherapy, been treated with sorafenib or other targeted therapy and are either intolerant to this treatment or show radiographic progression after treatment.
  2. Age 18-70 years old, male or female
  3. Biopsy shows negative allograft PD-L1 expression
  4. Child-Pugh score ≤ 6 points (Child-Pugh A)
  5. Estimated postoperative survival time ≥ 12 weeks
  6. ECOG score 0-1 points
  7. Laboratory test indicators: white blood cells ≥ 3.0 × 109 / L, platelets ≥ 80 × 109 / L, hemoglobin ≥ 100g / L; total bilirubin ≤ 2.5 times the upper limit of normal, transaminase (AST, ALT) ≤ 2.5 times Upper limit of normal value, serum creatinine ≤ 1.5 times normal upper limit
  8. Have sufficient understanding and voluntarily sign informed consent to participate in clinical research

Exclusion Criteria:

  1. Biopsy shows positive allograft PD-L1 expression
  2. Severe allergic reactions to other monoclonal antibodies
  3. Have any history of active autoimmune diseases or autoimmune diseases
  4. The presence of active infection with Hepatitis B or Hepatitis C Virus
  5. Severe cardiopulmonary dysfunction patients, have high blood pressure and blood pressure can not be controlled with drugs, unstable coronary artery disease (uncontrollable arrhythmia, unstable angina), non-compensatory congestive heart failure, within 6 months Myocardial infarction

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

JS001(PD-1 inhibitor), 240mg I.V. Q3W,

Outcomes

Primary Outcome Measures

Serious Adverse Event Rate
the occurrence rate of serious adverse event after PD-1 inhibitor treatment
Acute Graft Rejection Rate
the occurrence rate of acute graft rejection after PD-1 inhibitor treatment

Secondary Outcome Measures

Objective Response Rate
Objective Response Rate after PD-1 inhibitor treatment
Progression Free Survival Rate
survival time after PD-1 inhibitor treatment till tumor progression
Over all survival Rate
survival time after PD-1 inhibitor treatment till patient death

Full Information

First Posted
May 27, 2019
Last Updated
May 29, 2019
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03966209
Brief Title
Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant
Official Title
Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Transplantation
Keywords
Checkpoint Inhibitor, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
JS001(PD-1 inhibitor), 240mg I.V. Q3W,
Intervention Type
Drug
Intervention Name(s)
JS001(PD-1 inhibitor)
Intervention Description
240mg I.V. Q3W
Primary Outcome Measure Information:
Title
Serious Adverse Event Rate
Description
the occurrence rate of serious adverse event after PD-1 inhibitor treatment
Time Frame
1.5 years
Title
Acute Graft Rejection Rate
Description
the occurrence rate of acute graft rejection after PD-1 inhibitor treatment
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Objective Response Rate after PD-1 inhibitor treatment
Time Frame
3 years
Title
Progression Free Survival Rate
Description
survival time after PD-1 inhibitor treatment till tumor progression
Time Frame
3 years
Title
Over all survival Rate
Description
survival time after PD-1 inhibitor treatment till patient death
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with recurrence or metastases Hepatocellular carcinoma after liver transplantation that not suitable for surgical resection and Local treatments such as radiofrequency ablation, transcatheter arterial embolization and radiotherapy, been treated with sorafenib or other targeted therapy and are either intolerant to this treatment or show radiographic progression after treatment. Age 18-70 years old, male or female Biopsy shows negative allograft PD-L1 expression Child-Pugh score ≤ 6 points (Child-Pugh A) Estimated postoperative survival time ≥ 12 weeks ECOG score 0-1 points Laboratory test indicators: white blood cells ≥ 3.0 × 109 / L, platelets ≥ 80 × 109 / L, hemoglobin ≥ 100g / L; total bilirubin ≤ 2.5 times the upper limit of normal, transaminase (AST, ALT) ≤ 2.5 times Upper limit of normal value, serum creatinine ≤ 1.5 times normal upper limit Have sufficient understanding and voluntarily sign informed consent to participate in clinical research Exclusion Criteria: Biopsy shows positive allograft PD-L1 expression Severe allergic reactions to other monoclonal antibodies Have any history of active autoimmune diseases or autoimmune diseases The presence of active infection with Hepatitis B or Hepatitis C Virus Severe cardiopulmonary dysfunction patients, have high blood pressure and blood pressure can not be controlled with drugs, unstable coronary artery disease (uncontrollable arrhythmia, unstable angina), non-compensatory congestive heart failure, within 6 months Myocardial infarction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowu Huang, M.D.
Phone
+86-13701811021
Email
huang.xiaowu@zs-hospital.sh.cn
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyu Wang
Phone
+86-21-64041990
Ext
2220
Email
wang.xiangyu@zs-hospital.sh.cn

12. IPD Sharing Statement

Learn more about this trial

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

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