A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

Tongji Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lenvatinib; Procedure: Transarterial Chemoembolization (TACE); Drug: Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06089382

Adjuvant-02

Details and patient eligibility

About

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.

Enrollment: 104 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 portal vein tumor thrombus (PVTT)
• Aged 18-75 years
• No previous systematic treatment and locoregional therapy for HCC prior to randomization
• 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
• 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
• Active or history of autoimmune disease
• 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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104 participants in 2 patient groups

Sintilimab Plus Lenvatinib

Experimental group

Treatment:

Drug: Sintilimab

Drug: Lenvatinib

TACE(one cycle) + active surveillance

Active Comparator group

Treatment:

Procedure: Transarterial Chemoembolization (TACE)