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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03778957




Registration number
NCT03778957
Ethics application status
Date submitted
28/11/2018
Date registered
19/12/2018
Date last updated
5/09/2024

Titles & IDs
Public title
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
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)
Secondary ID [1] 0 0
2018-002134-20
Secondary ID [2] 0 0
D933GC00001
Universal Trial Number (UTN)
Trial acronym
EMERALD-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Bevacizumab
Other interventions - Placebo
Treatment: Surgery - Transarterial Chemoembolization (TACE)

Experimental: Arm A - Transarterial Chemoembolization (TACE) in combination with Durvalumab

Experimental: Arm B - Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab

Placebo comparator: Arm C - Transarterial Chemoembolization (TACE) in combination with Placebos


Treatment: Drugs: Durvalumab
Durvalumab IV (intravenous)

Treatment: Drugs: Bevacizumab
Bevacizumab IV (intravenous)

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

Treatment: Surgery: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) for Arm B vs Arm C
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) for Arm A vs Arm C
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Approximately 5 years
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Approximately 5 years

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
Accrual to date
Final
724
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Benowa
Recruitment hospital [2] 0 0
Research Site - Box Hill
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Clayton
Recruitment hospital [5] 0 0
Research Site - Herston
Recruitment hospital [6] 0 0
Research Site - Liverpool
Recruitment hospital [7] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment outside Australia
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San Sebastián(Guipuzcoa)
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Ho Chi Minh City
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Trial website
https://clinicaltrials.gov/study/NCT03778957
Trial related presentations / publications
Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
Bruno Sangro, MD
Address 0 0
Clinica Universidad de Navarra
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03778957