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

NCT04738188 | Unknown

• 1 other identifier: 19229-0-02
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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

Keywords

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Downstaging success rate

  Criteria for success rate in downstaging meet UCSF criteria or the standard for liver resection.

  Within 6 months after surgery

Secondary Outcomes (13)

• Complete response (CR)

  1, 3, 6 months after surgery

• Partial response (PR)

  1, 3, 6 months after surgery

• Stable disease (SD)

  up to 6months after TACE procedure

• Progressive disease (PD)

  1, 3, 6 months after surgery

• Objective response (OR)

  1, 3, 6 months after surgery

Study Arms (2)

Drug-eluting bead transarterial chemoembolization(DEB-TACE)

EXPERIMENTAL

Procedure: DEB-TACE; Device: Drug-eluting Beads; Drug: Epirubicin

conventional transarterial chemoembolization(cTACE)

ACTIVE COMPARATOR

Procedure: cTACE; Drug: Epirubicin

Interventions

DEB-TACE PROCEDURE

Drug-eluting beads transcatheter arterial chemoembolization

Drug-eluting bead transarterial chemoembolization(DEB-TACE)

cTACE PROCEDURE

Transcatheter arterial chemoembolization

conventional transarterial chemoembolization(cTACE)

Drug-eluting Beads DEVICE

Drug-eluting beads

Drug-eluting bead transarterial chemoembolization(DEB-TACE)

Epirubicin DRUG

Chemotherapy drug for intra-arterial infusion

Drug-eluting bead transarterial chemoembolization(DEB-TACE); conventional transarterial chemoembolization(cTACE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age, of any sex;
• 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);
• 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;
• Patients with stage Ib，IIa，IIb in China liver cancer staging (CNLC) ;
• Child-Pugh's grade A or B (no more than 7 score);
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
• Patients with hepatitis B virus (HBV) infection should receive routine antiviral therapy;
• The function of main organs is normal and meet the following criteria:

You may not qualify if:

• Patients with extrahepatic metastasis or main portal vein /main hepatic vein invasion;
• Patients with diffuse liver cancer;
• 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%;
• 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;
• Patients unsuitable for the study in the opinion of the Investigator;
• Pregnant or breastfeeding women; women of childbearing ages unless using effective contraception;
• Patients with mental disorders or history of abuse of psychotropic substances;
• Infection with human immunodeficiency virus (HIV);
• A history of liver resection, liver transplantation, interventional therapy, or combined with other malignant tumors;
• Patients with active infection;
• Patients with contraindications to TACE or epirubicin;
• Floating population or with poor compliance;
• Patients in other clinical trials conducting with experimental-related drugs or devices within 4 weeks.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Epirubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Jiahong Dong, MD

CONTACT

01056118763; dongjiahong@mail.tsir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: February 4, 2021
• Study Start: March 18, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2025
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)