- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04682210
Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection (DaDaLi)
December 20, 2020 updated by: Chen Min-Shan, Sun Yat-sen University
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
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
246
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhongguo Zhou
- Phone Number: 020-87343585
- Email: 54757370@qq.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Sun yat-sen University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
|
Sintilimab 200mg IV Q3W
Other Names:
Bevacizumab 7.5mg/kg IV Q3W
Other Names:
|
No Intervention: Arm B
Active surveillance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
up to 36 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 48 months after randomization
|
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.
|
at 12 and 24 months after randomization
|
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.
|
at 24 and 36 months after randomization
|
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.
|
up to 36 months after randomization
|
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.
|
up to 48 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
December 20, 2020
First Submitted That Met QC Criteria
December 20, 2020
First Posted (Actual)
December 23, 2020
Study Record Updates
Last Update Posted (Actual)
December 23, 2020
Last Update Submitted That Met QC Criteria
December 20, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2020-280-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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