A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patien… (NCT04102098) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
United States668 participantsStarted 2019-12-31
Plain-language summary
This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only) within 4-12 weeks prior to randomization
* Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA only)
* Absence of major macrovascular invasion (except Vp1/Vp2) and extrahepatic spread
* Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following curative procedure
* Full recovery from surgical resection or ablation within 4 weeks prior to randomization
* High risk for HCC recurrence after resection or ablation
* For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
* For patients with resected HCC, availability of a representative baseline tumor tissue sample
* ECOG Performance Status of 0 or 1
* Child-Pugh Class A status
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion Criteria:
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Evidence of residual, recurrent, or metastatic disease a…
What they're measuring
1
Recurrence-Free Survival (RFS), as Determined by IRF