A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2024-08-19
• Target enrollment: 0
• Participant gender: All

Summary

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Bevacizumab; Durvalumab

Criteria

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