問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberD933GC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03778957
Active

2018-11-30 - 2025-12-31

Phase III

Recruiting9

ICD-10C22.0

Liver cell carcinoma

ICD-10C22

Malignant neoplasm of liver and intrahepatic bile ducts

ICD-9155.0

Malignant neoplasm of liver, primary

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)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chang-Fang Chiu Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 紀廣明 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator San-Chi Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator TENG-YU LEE Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital Yunlin Branch 

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林正耀 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Shi-Ming Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Taiwan National PI

林錫銘

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Recruiting

Audit

None

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Ting-Tsung Chang Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Locoregional Hepatocellular Carcinoma

Objectives

Primary Objective: To assess the efficacy of Arm A compared with Arm C Key Secondary Objectives To assess the efficacy of Arm B compared with Arm C To assess the efficacy of Arm A compared with Arm C as well as Arm B compared with Arm C To assess disease-related symptoms, impacts, and HRQoL in patients treated in Arm A compared with Arm C as well as Arm B compared with Arm C

Test Drug

DURVALUMAB (IMFINZI, MEDI4736)

Active Ingredient

Bevacizumab
Durvalumab (MEDI4736)

Dosage Form

Dosage

50
25

Endpoints

Primary Outcome Measures :
Progression Free Survival (PFS) for Arm B vs Arm C [ Time Frame: 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 :
Progression Free Survival (PFS) for Arm A vs Arm C [ Time Frame: 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) [ Time Frame: Approximately 5 years ]
OS is defined as the time from the date of randomization until death due to any cause

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) [ Time Frame: 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

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) [ Time Frame: Approximately 5 years ]
Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms

Inclution Criteria

Inclusion criteria
Patients are eligible to be included in the study only if all of the following inclusion criteria and
none of the exclusion criteria apply:
Informed consent
1. Provision of signed and dated, written informed consent form (ICF) and any locally
required authorization (eg, Health Insurance Portability and Accountability Act in the
United States, European Union Data Privacy Directive in the European Union)
obtained from the patient/legal representative prior to any mandatory study specific
procedures, sampling, and analyses.
2. Provision of signed and dated written genetic informed consent prior to optional
collection of sample for genetic analysis
The ICF process is described in Appendix A 3.
Age
3. Age ≥18 years at the time of screening. For patients aged <20 years and enrolled in
Japan, a written informed consent should be obtained from the patient and his or her
legally acceptable representative.
Type of patient and disease characteristics
4. Confirmed HCC based on histopathological findings from tumor tissue
5. No evidence of extrahepatic disease on baseline chest/abdomen/pelvis imaging
6. Disease not amenable to curative surgery or transplantation or curative ablation
7. Disease must be amenable to TACE and anticipated to require no more than 4 TACE
treatments to treat sites of disease within a ≤16-week period (Permitted modalities are
DEB-TACE or cTACE (using an emulsion of Lipiodol®
and a permitted
chemotherapeutic agent as per institutional practice, followed by embolizing agents).
8. Child-Pugh score class A to B7
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at
enrollment
10. Patients with HBV infection, which is characterized by positive hepatitis B surface
antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable
HBV DNA (≥10 IU/ml or above the limit of detection per local lab standard), must be
treated with antiviral therapy, as per institutional practice, to ensure adequate viral
suppression (HBV DNA ≤2000 IU/mL) prior to enrollment. Patients must remain on
antiviral therapy for the study duration and for 6 months after the last dose of study
medication. Patients who test positive for anti-hepatitis B core (HBc) with
undetectable HBV DNA (<10 IU/ml or under the limit of detection per local lab standard) do not require anti-viral therapy prior to enrollment. These subjects will be
tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV
DNA is detected (≥10 IU/ml or above the limit of detection per local lab standard).
HBV DNA detectable subjects must initiate and remain on antiviral therapy for the
study duration and for 6 months after the last dose of study medication.
11. Patients with HCV infection must have management of this disease per local
institutional practice throughout the study. HCV diagnosis is characterized by the
presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon
enrollment.
12. At least 1 measurable intrahepatic lesion suitable for repeat assessments according to
the following mRECIST criteria:
 Liver lesions that show typical features of HCC on IV contrast-enhanced CT or
MRI scans, ie, hypervascularity in the arterial phase with washout in the portal or
the late venous phase
 Viable, non-necrotic portion (arterial phase IV contrast-enhancing) that can be
accurately measured at baseline as ≥10 mm in the longest diameter
13. Adequate organ and marrow function as defined below. Criteria “a,” “b,” “c,” and “f”
may not be met with transfusions, infusions, or growth factor support administered
within 14 days of starting the first dose.
(a) Hemoglobin ≥9.0 g/dL
(b) Absolute neutrophil count ≥1000/µL
(c) Platelet count ≥75000/µL
(d) Total bilirubin ≤2.0 × the upper limit of normal (ULN)
(e) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
≤5 × ULN
(f) Albumin ≥2.8 g/dL
(g) International normalized ratio ≤1.6
(h) 2+ or less urine dipstick reading
(i) Calculated creatinine clearance (CL) ≥30 mL/min as determined by
Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine CL
14. Must have a life expectancy of at least 12 weeks.
Weight
15. Body weight >30 kg
Sex
16. Male and/or female

Exclusion Criteria

Exclusion criteria
Medical conditions
1. Any history of nephrotic or nephritic syndrome
2. Clinically significant (eg, active) cardiovascular disease, including:
 Unstable angina within ≤6 months of randomization
 New York Heart Association Grade ≥2 congestive heart failure
 Poorly controlled cardiac arrhythmia despite medication (patient with rate
controlled atrial fibrillation are eligible), or any clinically significant abnormal
finding on resting ECG
 Peripheral vascular disease Grade ≥3 (eg, symptomatic and interfering with
activities of daily living requiring repair or revision)
 Previous transient ischemic attack, or sub-arachnoids hemorrhage within
6 months prior to randomization
3. Significant traumatic injury during 4 weeks prior to randomization
4. Known hereditary predisposition to bleeding or thrombosis; any prior or current
evidence of bleeding diathesis.
5. Systemic anticoagulation allowed, excluding Vitamin K antagonists
6. History of arterioembolic event including a stroke or myocardial infarction
7. Non-healing wound, active ulcer, or bone fracture. Patients with granulating incisions
healing by secondary intention with no evidence of facial dehiscence or infection are
eligible but require wound examinations every 3 weeks.
8. 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
9. Patients who have had any kind of surgery in the past 28 days (diagnostic biopsy
included)
10. Uncontrolled hypertension defined by a systolic pressure >150 mmHg or diastolic
pressure >90 mmHg, with or without antihypertensive medication. Patients with initial
blood pressure (BP) elevations are eligible if initiation or adjustment of
antihypertensive medication lowers pressure to meet entry criteria.
11. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
12. History of hepatic encephalopathy within past 12 months or requirement for
medications to prevent or control encephalopathy (no lactulose, rifaximin, etc, if used
for purposes of hepatic encephalopathy)
13. Clinically meaningful ascites, defined as ascites requiring non-pharmacologic
intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior
to the first scheduled dose.
 Patients with ascites that has required pharmacologic intervention (eg, diuretics)
and who have been on stable doses of diuretics for ascites for ≥2 months are
eligible.
14. Major portal vein thrombosis visible on baseline/eligibility imaging, patients with Vp3
and Vp4 are excluded
15. Patients with infiltrative-type HCC
16. History of allogeneic organ transplantation
17. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the
exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or
Wegener syndrome [eg, granulomatosis with polyangiitis, Graves’ disease, rheumatoid
arthritis, hypophysitis, and uveitis]). The following are exceptions to this criterion:
 Patients with vitiligo or alopecia
 Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement
 Any chronic skin condition that does not require systemic therapy
 Patients without active disease in the last 5 years may be included but only after
consultation with the Study Physician
 Patients with celiac disease controlled by diet alone
18. Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection (except for noted HBV or HCV as detailed above), symptomatic congestive
heart failure, poorly controlled diabetes mellitus, uncontrolled hypertension, unstable
angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic GI
conditions associated with diarrhea, or psychiatric illness/social situations that would
limit compliance with study requirement, substantially increase risk of incurring AEs
or compromise the ability of the patient to give written informed consent
19. History of another primary malignancy except for
 Malignancy treated with curative intent and with no known active disease
≥5 years before the first dose of IP and of low potential risk for recurrence
 Adequately treated non-melanoma skin cancer or lentigo maligna without
evidence of disease
 Adequately treated carcinoma in situ without evidence of disease
20. History of leptomeningeal carcinomatosis
21. History of active primary immunodeficiency
22. Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and tuberculosis testing in
line with local practice) or human immunodeficiency virus (positive HIV 1/2
antibodies).
23. Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D
virus (HDV). (HBV infection is indicated by the presence of HBsAg and/or
anti-HBcAb with detectable HBV DNA ≥10 IU/mL or above the limit of detection per
local lab standard; HCV positive infection is characterized by the presence of
detectable HCV RNA; HDV positive infection is indicated by the presence of
anti-HDV antibodies.)
24. Any unresolved toxicity National Cancer Institute (NCI) CTCAE v5.0 Grade ≥2 from
previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory
values defined in the inclusion criteria
25. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
excipients
26. History of allogeneic bone marrow transplant and active chronic graft versus host
disease
Prior/concomitant therapy
27. Receipt of anti-PD-1, anti-PD-L1, or anti-CTLA-4 prior to the first dose of IP
28. Receipt of prior TACE, prior bland embolization, or prior radioembolization
29. Receipt of prior systemic anticancer therapies for HCC
30. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note:
Patients, if enrolled, should not receive live vaccine while receiving IP and up to
30 days after the last dose of IP.
31. Current or prior use of immunosuppressive medication within 14 days before the first
dose of IP. The following are exceptions to this criterion:
 Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular
injection)
 Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or its equivalent
 Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication)
Prior/concurrent clinical study experience
32. Previous IP assignment in the present study
33. Concurrent enrollment in another clinical study, unless it is an observational
(non-interventional) clinical study or during the follow-up period of an interventional
study
34. Prior randomization or treatment in a previous durvalumab clinical study regardless of
treatment group assignment
Other exclusions
35. Female patients who are pregnant or breastfeeding or male or female patients of
reproductive potential who are not willing to employ highly effective birth control
from screening to 6 months after the last dose of IP. Not engaging in sexual activity, as
per the patient’s preferred and usual lifestyle, for the total duration of the treatment
and washout periods is an acceptable practice.
36. Judgment by the Investigator that the patient should not participate in the study if the
patient is unlikely to comply with study procedures, restrictions, and requirements
37. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site)
Genetics research study (optional)
38. Exclusion criteria for participation in the optional (DNA) genetics research component
of the study include:
 Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample
collection

The Estimated Number of Participants

  • Taiwan

    72 participants

  • Global

    720 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB