Withdrawn (No participants enrolled)
April 18, 2019
June 3, 2019
The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with toripalimab in patients with advanced hepatocellular carcinoma (HCC)
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus toripalimab. Thus, the investigators carried out this single-arm, prospective, phase II study to find out it.
|Experimental: Lenvatinib Plus Toripalimab
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 21-day treatment cycles, and received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
12 mg (or 8 mg) once daily (QD) oral dosing
240mg intravenously every 3 weeks
- 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 systemic treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured
- 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
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or
- 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
- Known central nervous system tumors including metastatic brain disease
Cancer Center Sun Yat-sen University
Sun Yat-sen University