Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

Tongji Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sintilimab (9 cycles); Drug: Sintilimab (18 cycles); Other: Active surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT06089369

Adjuvant-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Sintilimab for six months group (9 cycles)

Experimental group

Description:

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.

Treatment:

Drug: Sintilimab (9 cycles)

Sintilimab for one year group (18 cycles)

Experimental group

Description:

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.

Treatment:

Drug: Sintilimab (18 cycles)

Active surveillance

Active Comparator group

Description:

Patients are closely monitored postoperatively.

Treatment:

Other: Active surveillance