Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

NCT ID: NCT06089369

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-11-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab for six months group (9 cycles)

Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred.

Group Type: EXPERIMENTAL

Sintilimab (9 cycles)

Intervention Type: DRUG

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

Sintilimab for one year group (18 cycles)

Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred.

Group Type: EXPERIMENTAL

Sintilimab (18 cycles)

Intervention Type: DRUG

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

Active surveillance

Patients are closely monitored postoperatively.

Group Type: ACTIVE_COMPARATOR

Active surveillance

Intervention Type: OTHER

Active surveillance

Interventions

Sintilimab (9 cycles)

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

Intervention Type: DRUG

Sintilimab (18 cycles)

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

Intervention Type: DRUG

Active surveillance

Active surveillance

Intervention Type: OTHER

Other Intervention Names

IBI 308; IBI 308

Eligibility Criteria

Inclusion Criteria

• Subjects with a histopathological diagnosis of HCC
• Undergone a curative resection
• Pathologically confirmed HCC with microvascular invasion (MVI)
• Aged 18-75 years
• No previous systematic treatment and locoregional therapy for HCC prior to randomization
• Absence of major macrovascular invasion
• No extrahepatic spread
• Full recovery from Curative resection within 4 weeks prior to randomization
• Child-Pugh: Grade A or B(7)
• ECOG-PS score: 0 or 1
• Subjects with HCV- RNA (+) must receive antiviral therapy
• Adequate organ function

Exclusion Criteria

• Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
• Any preoperative treatment for HCC including local and systemic therapy
• Have received more than 1 cycle of adjuvant TACE following surgical resection
• Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
• Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
• Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
• Cardiac clinical symptom or cardiovascular disease that is not well controlled
• Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
• Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
• Inability or refusal to comply with the treatment and monitoring

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaoping

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Countries

China

Central Contacts

Xiaoping Chen, Prodessor

Role: CONTACT

chenxpchenxp@163.com

02783665213

Other Identifiers

Adjuvant-01

Identifier Type: -

Identifier Source: org_study_id