Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC

• Status: Withdrawn
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with lenvtinib Alone in patients with advanced hepatocellular carcinoma (HCC)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangzhou No.12 People's Hospital; Kaiping Central Hospital; The First Affiliated Hospital of University of South China
• Treatments: Antibodies; Immunoglobulins; Lenvatinib

Criteria

Inclusion Criteria:

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)

• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.

• Barcelona clinic liver cancer-stage C

• Eastern Cooperative Oncology Group performance status of 0 to 2

• with no previous treatment

• No Cirrhosis or cirrhotic status of Child-Pugh class A only

• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.

• The following laboratory parameters:

• Platelet count ≥ 75,000/μL

• Hemoglobin ≥ 8.5 g/dL

• Total bilirubin ≤ 30mmol/L

• Serum albumin ≥ 30 g/L

• ASL and AST ≤ 5 x upper limit of normal

• Serum creatinine ≤ 1.5 x upper limit of normal

• INR ≤ 1.5 or PT/APTT within normal limits

• Absolute neutrophil count (ANC) >1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

• Known history of HIV

• History of organ allograft

• Known or suspected allergy to the investigational agents or any agent given in association with this trial.

• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• Evidence of bleeding diathesis.

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

• Known central nervous system tumors including metastatic brain disease