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

NCT ID: NCT03969576

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2022-06-15

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DEB-TACE

172 subjects in this study group will be receive the treatment of drug-eluting bead TACE

Group Type: EXPERIMENTAL

DEB-TACE

Intervention Type: PROCEDURE

Patients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated "on demand" according to the radiological response.

cTACE

172 subjects in this study group will be receive the treatment of conventional TACE

Group Type: ACTIVE_COMPARATOR

cTACE

Intervention Type: PROCEDURE

Patients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated "on demand" according to the radiological response.

Interventions

DEB-TACE

Patients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated "on demand" according to the radiological response.

Intervention Type: PROCEDURE

cTACE

Patients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated "on demand" according to the radiological response.

Intervention Type: PROCEDURE

Other Intervention Names

drug-eluting bead transarterial chemoembolisation; conventional transarterial chemoembolisation

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Guohong Han

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Guohong Han, MD PHD

Role: CONTACT

hangh@fmmu.edu.cn

+86-2984771528

Dongdong Xia, MD

Role: CONTACT

xiadongdong1026@163.com

+86-2984771528

Other Identifiers

DEB-TACE-HCC

Identifier Type: -

Identifier Source: org_study_id