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NOT YET RECRUITING
NCT06089382
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Sintilimab

IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence)

DRUG

Lenvatinib

8mg orally once a day for 1 year

PROCEDURE

Transarterial Chemoembolization (TACE)

One cycle of TACE postoperatively

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China