Overview

Lenvatinib Plus PD-1 Antibody for Intermediate-stage HCC Beyond Up-to-seven Criteria

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Withdrawn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 for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shi Ming
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 B

- Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the
size of the largest tumor [in cm] and the number of tumors)

- Eastern Cooperative Oncology Group performance status of 0 to 1

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

- Not applicable for transarterial chemoembolization, surgical resection, and local
ablative therapy.

- 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