A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab … (NCT03778957) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
United States724 participantsStarted 2018-11-30
Plain-language summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Who can participate
Age range18 Years – 110 Years
SexALL
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Key Inclusion Criteria:
* No evidence of extrahepatic disease
* Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
* Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
* Adequate organ and marrow function
Key Exclusion Criteria
* Any history of nephrotic or nephritic syndrome
* Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
* Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
* History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
* Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
What they're measuring
1
Progression Free Survival (PFS) for Arm B vs Arm C