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Clinical Trials List

Protocol NumberD910DC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03847428
Active

2019-07-01 - 2026-06-30

Phase III

Recruiting9

ICD-10C22.8

Malignant neoplasm of liver, primary, unspecified as to type

hase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Hao-Jan Lei Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shi-Ming Lin Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇維文 Digestive System Department
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Hung Chen Division of General Internal Medicine
National Taiwan University Hospital Yunlin Branch 

Co-Principal Investigator

  • 吳立偉 Division of General Internal Medicine
  • 余健鈞 Division of General Internal Medicine
  • 吳昭瑩 Division of General Surgery
  • 李基裕 Division of General Internal Medicine
  • 郭家旗 Division of General Internal Medicine
  • 楊宗樺 Division of General Internal Medicine
  • 邱敏欽 Division of General Internal Medicine
  • 方佑仁 Division of General Internal Medicine
  • 謝宏仁 Division of Radiology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Chih Ho Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方佑仁 無
National Taiwan University Hospital Yunlin Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方佑仁 Division of General Internal Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.

Test Drug

Durvalumab (IMFINZI); Bevacizumab (Avastin)

Active Ingredient

Bevacizumab
Durvalumab

Dosage Form

injection

Dosage

50
25

Endpoints

Primary Outcome Measures :
Recurrence-free survival (RFS) for Arm B vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
Recurrence-free survival (RFS) Arm A vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.

Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: At 36 (OS36) and 48 months (OS48) after first patient randomized ]
OS is defined as the time from the date of randomization until death due to any cause

Recurrence-free survival at 24 months (RFS24) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 24 months ]
Proportion of RFS at 24 months

Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
TTR is defined as the time from the date of randomization until the date of disease recurrence

Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)

Inclution Criteria

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 US,
EU Data Privacy Directive in the EU) obtained from the patient/legal representative prior
to any mandatory study-specific procedures, sampling, and analyses, including screening
evaluations.
2 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.
3 Histologically or cytologically confirmed HCC and successfully completed curative
therapy (resection or ablation).
(a) Hepatic resection and have the following pathologic findings from surgery:
(i) Any size with microvascular invasion (clear pathology assessment on
microvascular invasion: Yes or No) or satellite tumor
(ii) 3 or less tumors, with at least one >5 cm
(iii) 4 or more tumors, ≤5 cm each
(b) Ablation (radiofrequency or microwave, cryoablation, or PEI per institutional
standard) and have the following radiologic findings prior to ablation:
(i) Solitary tumor, 3 to 5 cm
(ii) 2 to 4 tumors, ≤5 cm each
(iii) Exclude patients with 5 or more tumors.
4 Patients must be randomized within 12 weeks after completion of curative hepatic
resection or ablation.
5 Imaging to confirm disease-free status within 28 days prior to randomization.
6 Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 at
enrollment.
7 Child-Pugh score of 5 or 6.
8 Patients with HBV infection (as characterized by positive hepatitis B virus surface
antigen [HBsAg] and/or anti-hepatitis B core antibodies (cAbs) with detectable HBV deoxyribonucleic acid (DNA) [≥10 IU/mL or above the limit of detection per local
laboratory]) must receive antiviral therapy at least after enrollment (sign of ICF) per
institutional practice to ensure adequate viral suppression (HBV DNA ≤2000 IU/mL)
prior to randomization. Patients must remain on antiviral therapy for the study duration
and for 6 months after the last dose of study treatment.
9 Patients with HCV infection (as characterized by the presence of detectable HCV
ribonucleic acid (RNA) or anti-HCV antibody) must be managed per local institutional
practice for the study and for 6 months after the last dose of study treatment.
10 Evidence of post-menopausal status or negative urinary or serum pregnancy test for
female pre-menopausal patients. A definition of post-menopausal is provided in
Section 5.3.
11 Adequate organ and marrow function, as defined below. Criteria “a,” “b,” “c,” and “f”
cannot be met with transfusions, infusions, or growth factor support administered within
14 days of starting the first dose.
(a) Hemoglobin ≥9 g/dL
(b) Absolute neutrophil count ≥1000/µL
(c) Platelet count ≥100000/µL
(d) Total bilirubin (TBL) ≤2.0 × upper limit of normal (ULN)
(e) Aspartate aminotransferase (AST) and ALT ≤5 × ULN
(f) Albumin ≥2.8 g/dL
(g) International normalized ratio ≤1.6
(h) Urine protein 2+ or less
(i) Tested blood urea nitrogen or creatinine ≤1.5 × ULN or calculated creatinine
clearance (CL) ≥51 mL/min as determined by the Cockcroft-Gault formula (using
actual WT) or 24-hour urine creatinine CL
12 Male and female

Exclusion Criteria

1 History of deep vein thrombosis, pulmonary embolism, or any other significant
thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis
are not considered “significant”) during the 3 months prior to randomization.
2 History of significant bleeding disorders, vasculitis, or a significant bleeding episode from
the GI tract within 3 months prior to study randomization.
3 History of GI perforation and/or fistulae within 6 months prior to randomization.
4 Any history of nephrotic or nephritic syndrome.
5 Evidence of symptomatic congestive heart failure (New York Heart Association II to IV)
or symptomatic or poorly controlled cardiac arrhythmia.
6 History of arterial thrombotic event, including myocardial infarction, unstable angina,
cerebrovascular accident, or transient ischemic attack, within 6 months prior to
randomization.
7 Uncontrolled arterial hypertension defined by a systolic pressure ≥150 mm Hg or
diastolic pressure ≥90 mm Hg despite standard medical management.
8 Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to
randomization.
9 Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
10 Evidence of esophageal and/or gastric varices on upper endoscopy or contrast-enhanced
cross-sectional imaging.
11 Evidence of metastasis, macrovascular invasion, or co-existing malignant disease on
baseline imaging.
12 History of hepatic encephalopathy within 12 months prior to randomization or
requirement for medications to prevent or control encephalopathy (no lactulose, rifaximin,
etc, if used for purposes of hepatic encephalopathy).
13 Evidence of portal vein thrombosis.
14 Clinically meaningful ascites, defined as ascites requiring non-pharmacologic
intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to
the first dose of study treatment.
(a) Patients with ascites who have required pharmacologic intervention (eg, diuretics)
and who have been on stable doses of diuretics for ascites for ≥2 months before
randomization are eligible.
15 Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [except for
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:
(a) Patients with vitiligo or alopecia
(b) Patients with hypothyroidism (eg, following Hashimoto syndrome), stable on
hormone replacement
(c) Any chronic skin condition that does not require systemic therapy
(d) Patients without active disease in the last 5 years may be included but only after
consultation with the Study Physician
(e) Patients with celiac disease controlled by diet alone
16 Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection,
symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris,
uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic GI
conditions associated with diarrhea, or psychiatric illness/social situations that would
limit compliance with study requirements, substantially increase the risk of incurring AEs
or compromise the ability of the patient to give written informed consent.
17 History of another primary malignancy except for the following:
(a) Prostate cancer of pathologic stage less than or equal to T2cN0M0 determined from a
prior prostatectomy without biochemical recurrence and who, in the opinion of the
Investigator, are not deemed to require active intervention, or patients with incidental
histologic findings of prostate cancer that has not been treated prior to the study and
who do not require specific therapy for prostate cancer beyond the surgery described
in the Clinical Study Protocol and also are considered to be at low risk for recurrence
per the Investigator
(b) Malignancy treated with curative intent and with no known active disease ≥5 years
before the first dose of study treatment and of low potential risk for recurrence
(c) Adequately treated non-melanoma skin cancer or lentigo malignant without evidence
of disease
(d) Adequately treated carcinoma in situ without evidence of disease
18 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 (HIV; positive for HIV 1/2 antibodies).
19 Active co-infection with both HBV and HCV, or co-infected with HBV and hepatitis D
virus.
20 Known allergy or hypersensitivity to any of the study treatments or any of the study
treatment excipients.
21 Major surgery (as defined by the Investigator) within 28 days prior to randomization, or
central venous access device placement within 7 days prior to randomization.
22 Receipt of routine treatment for chronic condition with nonsteroidal anti-inflammatory
agents (eg, indomethacin, ibuprofen, naproxen, or similar agents) or other anti-platelet
agents (eg, clopidogrel, ticlopidine, dipyridamole, or anagrelide). Require minimum
washout period of 1 week prior to randomization.
23 Receipt of prior systemic anticancer therapy for HCC.
24 History of allogeneic organ transplantation or those who are on a waiting list for liver
transplantation.
25 Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
Note: Patients, if enrolled, should not receive live vaccine while receiving study treatment
and up to 30 days after the last dose of study treatment.
26 Current or prior use of immunosuppressive medication within 14 days before the first
dose of study treatment. The following are exceptions to this criterion:
(a) Intranasal, inhalational, topical steroids, or local steroid injections (eg, intra-articular
injection)
(b) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone
or its equivalent
(c) Steroids as pre-medication for hypersensitivity reactions (eg, CT-scan premedication)
Other exclusions
27 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 study treatment. Not engaging in sexual
activity, per the patient’s preferred and usual lifestyle, for the total duration of the
treatment and washout periods is an acceptable practice.
28 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.
29 Involvement in the planning and/or conduct of the study for both AstraZeneca staff and/or
staff at the study site.

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    1100 participants

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