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

Last updated: December 20, 2020
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Chemotherapy

Cancer Treatment

Vaccines

Treatment

N/A

Clinical Study ID

NCT04682210
B2020-280-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 transarterialchemoembolization 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

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 otherimmunotherapy
  • Pregnant or lactating women

Study Design

Total Participants: 246
Study Start date:
December 01, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

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