Hepatocellular Carcinoma
Conditions
Keywords
Programmed Cell Death 1, lysine kinase inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Portal vein tumor thrombus,PVTT
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.
Interventions
DRUGSintilimab
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence）
DRUGLenvatinib
8mg orally once a day for 1 year
One cycle of TACE postoperatively
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactXiaoping Chen, Prodessor
Outcome results
None listed