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

Trial number:
NCT03778957
Trial phase:
3
Study type:
immunotherapy, targeted, local
Overall status:
Recruiting

Study start date

November, 2018

Scientific title

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

Summary

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

Key - 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

- 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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Quadruple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes, Outcomes assessor masked: Yes,

Conditions

Hepatocellular Carcinoma

Other study ID numbers

D933GC00001; 2018-002134-20

Locations

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