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A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
Sponsor: Tongji Hospital
Summary
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.
Official title: A Phase III Trial of Sintilimab Plus Lenvatinib in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2023-11-01
Completion Date
2026-11-01
Last Updated
2023-10-18
Healthy Volunteers
No
Conditions
Interventions
Sintilimab
IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence)
Lenvatinib
8mg orally once a day for 1 year
Transarterial Chemoembolization (TACE)
One cycle of TACE postoperatively
Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China