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出境医 / 临床实验 / Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant

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

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.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Transplantation Drug: JS001(PD-1 inhibitor) Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : October 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: treatment
JS001（PD-1 inhibitor）, 240mg I.V. Q3W,
 Drug: JS001(PD-1 inhibitor)
240mg I.V. Q3W
Outcome Measures
Primary Outcome Measures :
  1. Serious Adverse Event Rate [ Time Frame: 1.5 years ]
    the occurrence rate of serious adverse event after PD-1 inhibitor treatment

  2. Acute Graft Rejection Rate [ Time Frame: 1.5 years ]
    the occurrence rate of acute graft rejection after PD-1 inhibitor treatment


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 3 years ]
    Objective Response Rate after PD-1 inhibitor treatment

  2. Progression Free Survival Rate [ Time Frame: 3 years ]
    survival time after PD-1 inhibitor treatment till tumor progression

  3. Over all survival Rate [ Time Frame: 3 years ]
    survival time after PD-1 inhibitor treatment till patient death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xiaowu Huang, M.D. +86-13701811021 huang.xiaowu@zs-hospital.sh.cn

Locations
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China, Shanghai
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiangyu Wang    +86-21-64041990 ext 2220    wang.xiangyu@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Serious Adverse Event Rate [ Time Frame: 1.5 years ]
    the occurrence rate of serious adverse event after PD-1 inhibitor treatment
  • Acute Graft Rejection Rate [ Time Frame: 1.5 years ]
    the occurrence rate of acute graft rejection after PD-1 inhibitor treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Objective Response Rate [ Time Frame: 3 years ]
    Objective Response Rate after PD-1 inhibitor treatment
  • Progression Free Survival Rate [ Time Frame: 3 years ]
    survival time after PD-1 inhibitor treatment till tumor progression
  • Over all survival Rate [ Time Frame: 3 years ]
    survival time after PD-1 inhibitor treatment till patient death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant
Official Title  ICMJE Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Liver Transplantation
Intervention  ICMJE Drug: JS001(PD-1 inhibitor)
240mg I.V. Q3W
Study Arms  ICMJE Experimental: treatment
JS001（PD-1 inhibitor）, 240mg I.V. Q3W,
Intervention: Drug: JS001(PD-1 inhibitor)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaowu Huang, M.D. +86-13701811021 huang.xiaowu@zs-hospital.sh.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966209
Other Study ID Numbers  ICMJE JS001LT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian Zhou, Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Zhongshan Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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