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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682210
Recruitment Status : Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Chen Min-Shan, Sun Yat-sen University

Study Description
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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

Condition or disease Intervention/treatment Phase
HCC Adjuvant Therapy Immunotherapy Drug: Sintilimab Drug: Bevacizumab Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-lable, Multi Center Study of Sintilimab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Curative Hepatic Resection
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
 Drug: Sintilimab
Sintilimab 200mg IV Q3W
Other Name: Tyvyt

Drug: Bevacizumab
Bevacizumab 7.5mg/kg IV Q3W
Other Name: Byvasda
No Intervention: Arm B
Active surveillance


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-free Survival (RFS) [ Time Frame: 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 Outcome Measures :
  1. Overall Survival (OS） [ Time Frame: up to 48 months after randomization ]
    OS is defined as the time from the date of randomisation until death due to any cause

  2. RFS Rate at 12 and 24 months [ Time Frame: 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.

  3. OS Rate at 24 and 36 Months [ Time Frame: 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.

  4. TTR(time to recurrence) [ Time Frame: up to 36 months after randomization ]
    TTR is defined as the time the date of randomisation until first documented disease recurrence.

  5. Adverse Events (AEs) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682210


Contacts
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Contact: Zhongguo Zhou 020-87343585 54757370@qq.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Responsible Party: Chen Min-Shan, MD, Department of Hepatobilliary Surgery, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04682210    
Other Study ID Numbers: B2020-280-01
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors