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

Hepatocellular Carcinoma Clinical Trial

Official title:

Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966209
• Other study ID #: JS001LT
• Status: Recruiting
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Xiaowu Huang, M.D.
• Phone: +86-13701811021
• Email: huang.xiaowu[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Transplantation

Intervention

Drug:
• JS001(PD-1 inhibitor)
240mg I.V. Q3W

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Event Rate	the occurrence rate of serious adverse event after PD-1 inhibitor treatment	1.5 years
Primary	Acute Graft Rejection Rate	the occurrence rate of acute graft rejection after PD-1 inhibitor treatment	1.5 years
Secondary	Objective Response Rate	Objective Response Rate after PD-1 inhibitor treatment	3 years
Secondary	Progression Free Survival Rate	survival time after PD-1 inhibitor treatment till tumor progression	3 years
Secondary	Over all survival Rate	survival time after PD-1 inhibitor treatment till patient death	3 years