Spots Global Cancer Trial Database for Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

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Trial Identification

Brief Title: Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

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

Study ID: NCT06089369

Conditions

Hepatocellular Carcinoma

Interventions

Sintilimab (9 cycles)

Sintilimab (18 cycles)

Active surveillance

Study Description

Brief 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.

Detailed Description: This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.