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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Transplantation; Hepatocellular Carcinoma
• Intervention / Treatment: Drug: JS001(PD-1 inhibitor)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Xiangyu Wang; Phone Number: 2220 +86-21-64041990; Email: wang.xiangyu@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; JS001（PD-1 inhibitor）, 240mg I.V. Q3W,	Drug: JS001(PD-1 inhibitor); 240mg I.V. Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Event Rate	the occurrence rate of serious adverse event after PD-1 inhibitor treatment	1.5 years
Acute Graft Rejection Rate	the occurrence rate of acute graft rejection after PD-1 inhibitor treatment	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Objective Response Rate after PD-1 inhibitor treatment	3 years
Progression Free Survival Rate	survival time after PD-1 inhibitor treatment till tumor progression	3 years
Over all survival Rate	survival time after PD-1 inhibitor treatment till patient death	3 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Immunotherapy; Checkpoint Inhibitor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: JS001LT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No