NCT04627012

Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

The Effectiveness and Safety of Lenvatinib Combined Anti-programmed Death Immunotherapy for the Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.

Detailed description

Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. We aimed to describe the efficacy and safety of Lenvatinib combined anti-PD1 antibody in patients with hepatocellular carcinoma who can not receive redical therapy.

Conditions

• Hepatocellular Carcinoma
• Anti-PD1 Antibody
• Liver Diseases

Interventions

Type	Name	Description
DRUG	Lenvatinib	12 mg (or 8 mg) once daily (QD) oral dosing.
DRUG	Opdivo	3mg/mg intravenously every 3 weeks
DRUG	Camrelizumab	200mg intravenously every 3 weeks
DRUG	Keytruda	200mg intravenously every 3 weeks
DRUG	Toripalimab	240mg intravenously every 3 weeks
DRUG	Sintilimab	200mg intravenously every 3 weeks
DRUG	Tislelizumab	200mg intravenously every 3 weeks

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-12-30
• Completion: 2023-07-01
• First posted: 2020-11-13
• Last updated: 2024-03-06

Locations

1 site across 1 country: China