Skip to content

Safety and efficacy study of PD-1/PD-L1 monotherapy after liver transplantation for hepatocellular carcinoma

Safety and efficacy study of PD-1/PD-L1 monotherapy after liver transplantation for hepatocellular carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049681
Enrollment
Unknown
Registered
2021-08-08
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Experimental group:PD-1/PD-L1 antibody
Control group:No PD-1/PD-L1 antibody

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 75 years old; 2) There was no history of serious arrhythmia and heart failure; 3) There was no history of severe ventilation dysfunction and severe pulmonary infection; 4) There was no acute or chronic renal failure. The creatinine clearance rate was more than 40 ml / min; 5) Good liver function: child Pugh grade A or B (= 28 g/L, AST, alt, ALP =1.5x10^9/L, Hb >=8.5 g/L, PLT >=75x10^9/L (no blood transfusion and drug treatment correction within 14 days before screening); 7) Coagulation function INR < = 2.3; 8) The pathological results were hepatocellular carcinoma (HCC); 9) Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) Those who have suffered from or are suffering from other malignant tumors; 3) Recurrent hepatocellular carcinoma; 4) Patients with mental illness were combined; 5) It is estimated that targeted drugs such as PD-1 monoclonal antibody sorafenib may be used after surgery; 6) Human immunodeficiency virus (HIV) carriers; 7) Patients with unresectable liver cancer or liver cancer who need liver transplantation; 8) Advanced hepatocellular carcinoma with systemic metastasis.

Design outcomes

Primary

MeasureTime frame
overall survival;Incidence of rejection reaction;

Secondary

MeasureTime frame
disease free survival;

Countries

China

Contacts

Public ContactWang Zhengxin

Huashan Hospital Affiliated to Fudan University

wangzhengxin@huashan.org.cn+86 13901677081

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026