Hepatocellular Carcinoma
Conditions
Keywords
Programmed Cell Death 1, Checkpoint Inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Microvascular Invasion
Brief summary
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.
Detailed description
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.
Interventions
DRUGSintilimab (9 cycles)
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles）
DRUGSintilimab (18 cycles)
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles）
OTHERActive surveillance
Active surveillance
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 microvascular invasion (MVI) * Aged 18-75 years * No previous systematic treatment and locoregional therapy for HCC prior to randomization * Absence of major macrovascular invasion * 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 * Subjects with HCV- RNA (+) must receive antiviral therapy * 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 * Cardiac clinical symptom or cardiovascular disease that is not well controlled * 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 60 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 ,24 , 36 , 60 Months | Randomization up to 60 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). |
| Overall Survival (OS) | Randomization up to 60 months | OS is defined as the time from randomization to death from any cause |
| Adverse events | Baseline up to 60 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 60 months | Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score |
Countries
China
Contacts
Primary ContactXiaoping Chen, Prodessor
Outcome results
None listed