Overview

Phase II of Lenvatinib Plus PD-1 Antibody for Advanced HCC

Status:
Withdrawn
Trial end date:
2019-12-01
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 in patients with advanced hepatocellular carcinoma (HCC)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
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