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

Phase 3

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Placebo; Drug: Durvalumab; Procedure: Transarterial Chemoembolization (TACE); Drug: Bevacizumab

• Registration Number: NCT03778957
• Lead Sponsor: AstraZeneca

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 durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy

Study Timeline

• Study First Submitted: 2018-11-28
• Study Start: 2018-11-30
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Primary Completion: 2023-09-11
• Disposition First Posted: 2024-08-09
• Disposition First Submitted: 2024-08-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 724

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C	Transarterial Chemoembolization (TACE)	Transarterial Chemoembolization (TACE) in combination with Placebos
Arm C	Placebo	Transarterial Chemoembolization (TACE) in combination with Placebos
Arm A	Placebo	Transarterial Chemoembolization (TACE) in combination with Durvalumab
Arm A	Transarterial Chemoembolization (TACE)	Transarterial Chemoembolization (TACE) in combination with Durvalumab
Arm B	Transarterial Chemoembolization (TACE)	Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Arm A	Durvalumab	Transarterial Chemoembolization (TACE) in combination with Durvalumab
Arm B	Durvalumab	Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Arm B	Bevacizumab	Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) for Arm B vs Arm C	Approximately 5 years	PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death

Secondary Outcome Measures

Name	Time	Method
Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)	Approximately 5 years	Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
Progression Free Survival (PFS) for Arm A vs Arm C	Approximately 5 years	PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death
Overall Survival (OS)	Approximately 5 years	OS is defined as the time from the date of randomization until death due to any cause
Disease-related symptoms measured by European Organization for Research and Treatment of Cancer (EORTC) 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)	Approximately 5 years	Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam