Efficacy and Safety of TACE on Downstaging Hepatocellular Carcinoma Beyond UCSF Criteria;

NCT ID: NCT04738188

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2025-12-31

Brief Summary

This is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma beyond University of California, San Francisco (UCSF) criteria.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-eluting bead transarterial chemoembolization(DEB-TACE)

Group Type: EXPERIMENTAL

DEB-TACE

Intervention Type: PROCEDURE

Drug-eluting beads transcatheter arterial chemoembolization

Drug-eluting Beads

Intervention Type: DEVICE

Drug-eluting beads

Epirubicin

Intervention Type: DRUG

Chemotherapy drug for intra-arterial infusion

conventional transarterial chemoembolization(cTACE)

Group Type: ACTIVE_COMPARATOR

cTACE

Intervention Type: PROCEDURE

Transcatheter arterial chemoembolization

Epirubicin

Intervention Type: DRUG

Chemotherapy drug for intra-arterial infusion

Interventions

DEB-TACE

Drug-eluting beads transcatheter arterial chemoembolization

Intervention Type: PROCEDURE

cTACE

Transcatheter arterial chemoembolization

Intervention Type: PROCEDURE

Drug-eluting Beads

Drug-eluting beads

Intervention Type: DEVICE

Epirubicin

Chemotherapy drug for intra-arterial infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 to 70 years of age, of any sex;

2. Patients who have histopathological or cytological proof of hepatocellular carcinoma (HCC) or meet the diagnostic criteria of Diagnosis, management, and treatment of hepatocellular carcinoma(V2017);

3. Beyond UCSF criteria: Diameter of single HCC lesion is between 6.5 cm and 10 cm; The number of tumors ≤3 with the maximum diameter of 4.5-5cm and the total diameter ≤10cm; Multiple HCC lesions ≤5 nodules, each lesion diameter≤4 cm with a total diameter ≤10 cm. Patients cannot be treated with resection or liver transplantation;

4. Patients with stage Ib，IIa，IIb in China liver cancer staging (CNLC) ;

5. Child-Pugh's grade A or B (no more than 7 score);

6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;

7. Patients with hepatitis B virus (HBV) infection should receive routine antiviral therapy;

8. The function of main organs is normal and meet the following criteria:

Exclusion Criteria

1. Patients with extrahepatic metastasis or main portal vein /main hepatic vein invasion;

2. Patients with diffuse liver cancer;

3. Patients with myocardial ischemia, myocardial infarction or poor controlled arrhythmia (including QTc≥470 ms) beyond stage Ⅱ; according to New York Heart Association (NYHA) standard, patients with heart failure in stage Ⅲ～Ⅳ; patients with an left ventricular ejection fraction(LVEF) <50%;

4. Abnormal coagulation （International Normalized Ratio(INR)>1.5, Prothrombin Time(PT)>ULN+4s or Activated Partial Thromboplastin Time (APTT) >1.5 ×ULN）,or patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;

5. Patients unsuitable for the study in the opinion of the Investigator;

6. Pregnant or breastfeeding women; women of childbearing ages unless using effective contraception;

7. Patients with mental disorders or history of abuse of psychotropic substances;

8. Infection with human immunodeficiency virus (HIV);

9. A history of liver resection, liver transplantation, interventional therapy, or combined with other malignant tumors;

10. Patients with active infection;

11. Patients with contraindications to TACE or epirubicin;

12. Floating population or with poor compliance;

13. Patients in other clinical trials conducting with experimental-related drugs or devices within 4 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tsinghua Chang Gung Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiahong Dong, MD

Role: CONTACT

dongjiahong@mail.tsir

01056118763

Facility Contacts

Jiahong Dong

Role: primary

13240009509

Other Identifiers

19229-0-02

Identifier Type: -

Identifier Source: org_study_id