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Clinical Trials in India / NCT03778957
Active, not recruiting Phase 3

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

NCT03778957 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2018-11-30
Last updated
2026-07-15

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

DurvalumabBevacizumabPlaceboTransarterial Chemoembolization (TACE)

Durvalumab: Durvalumab IV (intravenous)

Bevacizumab: Bevacizumab IV (intravenous)

Placebo: Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)

Transarterial Chemoembolization (TACE): TACE (chemo and embolic agent injection into the hepatic artery)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
110 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (166)

FacilityCityRegionStatus
Research Site Costa Mesa California
Research Site La Jolla California
Research Site Orange California
Research Site Washington D.C. District of Columbia
Research Site Jacksonville Florida
Research Site Miami Florida
Research Site Honolulu Hawaii
Research Site Chicago Illinois
Research Site Shreveport Louisiana
Research Site Detroit Michigan
Research Site Rochester Minnesota
Research Site St Louis Missouri
Research Site Stony Brook New York
Research Site Charlotte North Carolina
Research Site Cleveland Ohio
Research Site Portland Oregon
Research Site Pittsburgh Pennsylvania
Research Site Sioux Falls South Dakota
Research Site Memphis Tennessee
Research Site Dallas Texas
Research Site Dallas Texas
Research Site Houston Texas
Research Site Houston Texas
Research Site Milwaukee Wisconsin
Research Site Benowa Australia
Research Site Box Hill Australia
Research Site Camperdown Australia
Research Site Clayton Australia
Research Site Herston Australia
Research Site Liverpool Australia
Research Site Melbourne Australia
Research Site Barretos Brazil
Research Site Florianópolis Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Rio de Janeiro Brazil
Research Site Santa Maria Brazil
Research Site São José do Rio Preto Brazil
Research Site São Paulo Brazil

+ 126 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

More AstraZeneca trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03778957 on ClinicalTrials.gov ↗ ← All trials in India