Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC)

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: DEB-TACE; Procedure: cTACE

• Registration Number: NCT03969576
• Lead Sponsor: Air Force Military Medical University, China

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Study Start: 2020-09-15
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 344

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEB-TACE	DEB-TACE	172 subjects in this study group will be receive the treatment of drug-eluting bead TACE
cTACE	cTACE	172 subjects in this study group will be receive the treatment of conventional TACE

Primary Outcome Measures

Name	Time	Method
Objective response rate	Tumor response will be assessed at week 4 and week 12 after initiation of treatment and thereafter every 8 weeks, up to 1 year	the percentage of patients who achieved complete response (CR) and partial response (PR) as the best response, according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	The last patient has been on study for 1year	Progression-free survival (PFS) is measured from the treatment start until all-cause death or untreatable progression (vascular invasion, extra hepatic spread, the Eastern Cooperative Oncology Group (ECOG) performance status \>2, and Child-Pugh grade over C, but except hepatic new nodule)
Time to response	The last patient has been on study for 1year	Time to response (TTR) is measured from the treatment start to the firstly radiologically confirmed complete response or partial response.
Adverse event	The adverse event will be assessed during in hospital and every 4 weeks, up to 1year	The terms and grade of adverse event will be present according to the Common Terminology Criteria for Adverse Event (CTCAE version 4.0)
Overall survival	The last patient has been on study for 1year	Overall survival (OS) is measured from the treatment start until all-cause death or the last follow-up date
Time to progression	The last patient has been on study for 1year	Time to progression is measured from the treatment start to the radiologically confirmed progression
Duration of response	The last patient has been on study for 1year	Duration of response (DOR) is measured from the first-time confirmed complete response or partial response to the date of radiological progression

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China