A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT06089382
- Lead Sponsor
- Tongji Hospital
- 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 tumor thrombus (PVTT ) after hepatectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sintilimab Plus Lenvatinib Sintilimab - Sintilimab Plus Lenvatinib Lenvatinib - TACE(one cycle) + active surveillance Transarterial Chemoembolization (TACE) -
- Primary Outcome Measures
Name Time Method Recurrence-Free Survival (RFS) Randomization up to approximately 36 months RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
- Secondary Outcome Measures
Name Time Method Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score Baseline up to 36 months The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported
Quality of Life (QoL) Scale Score Baseline up to 36 months Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
RFS Rate at 12 and 24 Months up to 24 months Overall Survival (OS) Randomization up to approximately 36 months Adverse events (AEs) Randomization up to approximately 36 months The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China