Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection
NCT ID: NCT04682210
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
246 participants
INTERVENTIONAL
2020-12-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
Sintilimab
Sintilimab 200mg IV Q3W
Bevacizumab
Bevacizumab 7.5mg/kg IV Q3W
Arm B
Active surveillance
No interventions assigned to this group
Interventions
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Sintilimab
Sintilimab 200mg IV Q3W
Bevacizumab
Bevacizumab 7.5mg/kg IV Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Chen Min-Shan
MD, Department of Hepatobilliary Surgery
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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B2020-280-01
Identifier Type: -
Identifier Source: org_study_id