A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Programmed Cell Death 1, lysine kinase inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Portal vein tumor thrombus,PVTT
Eligibility Criteria
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
Sites / Locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sintilimab Plus Lenvatinib
TACE(one cycle) + active surveillance