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

NCT03966209 | Unknown Phase 1 DMC

• 1 other identifier: JS001LT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Liver Transplantation

Keywords

Checkpoint Inhibitor; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Objective Response Rate

  3 years

• Progression Free Survival Rate

  3 years

• Over all survival Rate

  3 years

Study Arms (1)

treatment

EXPERIMENTAL

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

Drug: JS001(PD-1 inhibitor)

Interventions

JS001(PD-1 inhibitor) DRUG

240mg I.V. Q3W

treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Xiaowu Huang, M.D.

CONTACT

+86-13701811021; huang.xiaowu@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 29, 2019
• Study Start: May 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: October 31, 2022
• Last Updated: May 31, 2019

Record last verified: 2019-05

Locations

CN (1)