Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection

Sponsor
Sun Yat-sen University
Study ID
NCT04682210
Phase
PHASE3
Status
Unknown

Conditions

  • Adjuvant Therapy
  • HCC
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab — DRUG
    Sintilimab 200mg IV Q3W
  • Bevacizumab — DRUG
    Bevacizumab 7.5mg/kg IV Q3W

Study Details

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

Key Dates

First listed
Dec 23, 2020
Start date
Dec 31, 2020
Status verified
Dec 2020
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
246 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
  • No Intervention: Arm B
    Active surveillance

Primary Outcome Measure

Recurrence-free Survival (RFS) [ Time Frame: up to 36 months after randomization ]

Central Contacts

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