Adjuvant Therapy, HCC, Immunotherapy
Conditions
Brief summary
This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection
Detailed description
There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.
Interventions
DRUGSintilimab
Sintilimab 200mg IV Q3W
DRUGBevacizumab
Bevacizumab 7.5mg/kg IV Q3W
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a first diagnosis of HCC who have undergone a curative resection * Radiologic evidence of disease free ≥4 weeks after complete surgical resection * Full recovery from surgical resection or post-operative transarterial chemoembolization before randomization * Randomization needs to occur within 12 weeks of the date of surgical resection * High risk for HCC recurrence as protocol defined * Child-Pugh Score, Class A * ECOG performance status 0 or 1 * No prior systemic anticancer therapy for HCC * Adequate hematologic and organ function
Exclusion criteria
* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC * Evidence of residual, recurrent, or metastatic disease at randomization * History of hepatic encephalopathy or organ transplantation * Patients who are in the waiting list for liver transplantation * Patients with Vp4 portal vein thrombosis * Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free Survival (RFS) | up to 36 months after randomization | RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS Rate at 12 and 24 months | at 12 and 24 months after randomization | RFS rate defined as the proportion of patients without recurrence or death from any cause at 12 and 24 months after randomization. |
| OS Rate at 24 and 36 Months | at 24 and 36 months after randomization | OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization. |
| Overall Survival (OS） | up to 48 months after randomization | OS is defined as the time from the date of randomisation until death due to any cause |
| TTR(time to recurrence) | up to 36 months after randomization | TTR is defined as the time the date of randomisation until first documented disease recurrence. |
| Adverse Events (AEs) | up to 48 months after randomization | The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v5.0 from the date of randomization to 90 days after last dose of study treatment. |
Countries
China
Contacts
Primary ContactZhongguo Zhou
Outcome results
None listed