Status:
ACTIVE_NOT_RECRUITING
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
Lead Sponsor:
AstraZeneca
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-110 years
Phase:
PHASE3
Brief Summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2026
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT03778957
Start Date
November 30 2018
End Date
August 31 2026
Last Update
October 10 2025
Active Locations (166)
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1
Research Site
Costa Mesa, California, United States, 92627
2
Research Site
La Jolla, California, United States, 92093-0698
3
Research Site
Orange, California, United States, 92868
4
Research Site
Washington D.C., District of Columbia, United States, 20007