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 therapy, Local/Regional therapies
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 diseaseDisease 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 syndromeClinically 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

Choose trial site (411)

National University Hospital 119228
National University Hospital 119228 Not yet recruiting
Singapore 119228
Curie Oncology (Novena)
Curie Oncology (Novena) Recruiting
Singapore 329563