Status:
NOT_YET_RECRUITING
A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
Lead Sponsor:
Tongji Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 tum...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06089382
Start Date
November 1 2023
End Date
November 1 2026
Last Update
October 18 2023
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030