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NOT YET RECRUITING
NCT06089369
PHASE3

Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

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) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.

Official title: Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-06-01

Completion Date

2026-11-30

Last Updated

2024-04-30

Healthy Volunteers

No

Interventions

DRUG

Sintilimab (9 cycles)

IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 9 cycles)

DRUG

Sintilimab (18 cycles)

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

OTHER

Active surveillance

Active surveillance

Locations (1)

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

Wuhan, Hubei, China