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The purpose of this study is to investigate the efficacy and safety of lenvatinib plus nivolumab compared with lenvatinib monotherapy for patients with advanced hepatitis B virus infection-related hepatocellular carcinoma.
Full description
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and nivolumab was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus nivolumab compared with lenvatinib monotherapy. Thus, the investigators carried out this prospective, randomized, phase IIb study to find out it.
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Inclusion criteria
Patients who meet all of the following criteria in screening tests and observations within 14 days before enrollment will be included in the study.
Signed Informed Consent Form
Males and Females, 18 years or older at time of signing Informed Consent Form
Ability to comply with the study protocol, in the investigator's judgment
HCC with diagnosis confirmed by histology/cytology by AASLD criteria
Barcelona clinic liver cancer (BCLC) C stage.
No prior systemic therapy for HCC
Patients must not be appropriate for surgery or loco-regional therapy. Patients can receive no previous anti-cancer therapy or have progressed or have intolerable adverse events after surgery or loco-regional therapy. Surgery or locoregional therapy include hepatic resection, ablation, transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiotherapy, and must have been completed at least 4 weeks (washout period) prior to the baseline scan. In addition, all acute toxic effects of the locoregional procedure must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade<=1.
At least one tumor lesion that can be accurately measured according to the RECIST 1.1
ECOG Performance Status of 0 or 1
No cirrhosis or cirrhotic status of Child-Pugh class A only. Documented virology status of HBV, as confirmed by screening HBV serology test, as evidenced by detectable HBV surface antigen. (there is no lower and upper limit of HBV DNA, but patients must be on effective antiviral therapy if HBV DNA is positive [greater than zero]).
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior torandomization, unless otherwise specified:
Reproductive status: Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within one day prior to the start of study drug. Women must not be breastfeeding.
Exclusion criteria
Patients who meet one of the following criteria in screening tests and observations before enrollment will be excluded from the study:
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0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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