Clinical trial NCT03969576: Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC)
Official title: Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Drug-eluting bead transarterial chemoembolization
Conventional transarterial chemoembolization
Objective response
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC


Eligibility criteria: Inclusion Criteria:

1. Prior informed consent
2. Confirmed Diagnosis of HCC: a. Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria. HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria. b. Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable
3. Patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage A and BCLC B, and all patients have a intermediate or high tumor burden (the diameter of largest tumor plus tumor number is more than 6)
4. Child Pugh class A/B(7) class without decompensated liver cirrhosis.
5. ECOG Performance Status 0 score
6. At least one uni-dimensional lesion measurable by MRI or CT according to the RECIST 1.1 criteria
7. Male or female subject larger than 18 years of age
8. Life expectance of at least 12 weeks.
9. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
10. Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:

    1. Hemoglobin \> 9.0 g/dl
    2. Absolute neutrophil count (ANC) \>1,500/mm3
    3. Platelet count≥50x109/L
    4. ALB≥28g/L
    5. Total bilirubin \< 2 mg/dL
    6. Alanine aminotransferase(ALT) and aspartate aminotransferase(AST) \< 5 x upper limit of normal
    7. Blood urea nitrogen(BUN) and creatinine \< 1.5 x upper limit of normal
    8. International normalized ratio(INR) \< 1.7, or prothrombin time（PT） \< 4 seconds above control

Exclusion Criteria:

1. Portal vein or any vascular invasion
2. Presence of extra hepatic spread
3. Presence of metastasis in biliary tract or obstruction of biliary tract
4. Presence of metastasis in brain or presence of symptom of the brain metastasis but lack of further examination to exclude brain metastasis
5. Poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by CT scan or MRI
6. Any contraindications for hepatic embolization procedures:

   1. Known hepatofugal blood flow
   2. Known porto-systemic shunt
   3. Renal failure / insufficiency requiring hemo-or peritoneal dialysis
7. History of cardiac disease:

   1. Congestive heart failure \>New York Heart Association (NYHA) class 2
   2. Uncontrolled hypertension
8. Known history of HIV infection
9. Patients who have previously been receiving any treatments against HCC
10. Active clinically serious infections (\> grade 2 NCI-CTCAE Version 4.0), except for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
11. Contraindication of Anthracyclines administration, such as Doxorubicin
12. Concurrent with other cancer
13. Pregnant or breast-feeding subjects
14. Women of childbearing age did not take any contraceptive measures
15. Clinically significant gastrointestinal bleeding within 12 weeks prior to start of study
16. Major surgery within 3 weeks prior to start of study drug (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed)

Primary outcomes:
measure: Objective response rate
timeFrame: Tumor response will be assessed at week 4 and week 12 after initiation of treatment and thereafter every 8 weeks, up to 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: The last patient has been on study for 1year
measure: Time to progression
timeFrame: The last patient has been on study for 1year
measure: Adverse event
timeFrame: The adverse event will be assessed during in hospital and every 4 weeks, up to 1year
measure: Progression-free survival
timeFrame: The last patient has been on study for 1year
measure: Time to response
timeFrame: The last patient has been on study for 1year
measure: Duration of response
timeFrame: The last patient has been on study for 1year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
Study officials:
References: