A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma Wi… (NCT06089382) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
China104 participantsStarted 2023-11-01
Plain-language 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 tumor thrombus (PVTT ) after hepatectomy.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Recurrence-Free Survival (RFS)
Timeframe: Randomization up to approximately 36 months