search
Back to results

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

Primary Purpose

HCC, Adjuvant Therapy, Immunotherapy

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Bevacizumab
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A

Arm B

Arm Description

sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W

Active surveillance

Outcomes

Primary Outcome Measures

Recurrence-free Survival (RFS)
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

Overall Survival (OS）
OS is defined as the time from the date of randomisation until death due to any cause
RFS Rate at 12 and 24 months
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
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
TTR(time to recurrence)
TTR is defined as the time the date of randomisation until first documented disease recurrence.
Adverse Events (AEs)
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.

Full Information

First Posted
December 20, 2020
Last Updated
December 20, 2020
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT04682210
Brief Title
Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection
Acronym
DaDaLi
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC, Adjuvant Therapy, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
Active surveillance
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
Tyvyt
Intervention Description
Sintilimab 200mg IV Q3W
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Byvasda
Intervention Description
Bevacizumab 7.5mg/kg IV Q3W
Primary Outcome Measure Information:
Title
Recurrence-free Survival (RFS)
Description
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).
Time Frame
up to 36 months after randomization
Secondary Outcome Measure Information:
Title
Overall Survival (OS）
Description
OS is defined as the time from the date of randomisation until death due to any cause
Time Frame
up to 48 months after randomization
Title
RFS Rate at 12 and 24 months
Description
RFS rate defined as the proportion of patients without recurrence or death from any cause at 12 and 24 months after randomization.
Time Frame
at 12 and 24 months after randomization
Title
OS Rate at 24 and 36 Months
Description
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
Time Frame
at 24 and 36 months after randomization
Title
TTR(time to recurrence)
Description
TTR is defined as the time the date of randomisation until first documented disease recurrence.
Time Frame
up to 36 months after randomization
Title
Adverse Events (AEs)
Description
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.
Time Frame
up to 48 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongguo Zhou
Phone
020-87343585
Email
54757370@qq.com
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs