Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma

NCT05053386 | Unknown

• 1 other identifier: IRB-2021-208
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, patients with hepatocellular carcinoma were used as the research object to explore the effectiveness and safety of idarubicin hepatic artery perfusion combined with lipiodol embolization, and to preliminarily explore the possibility of idarubicin in the treatment of hepatocellular carcinoma. Provide evidence-based medicine for the discovery of better TACE combined chemotherapy regimens for the treatment of hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate, ORR

  The number of cases that achieved complete remission (CR) or partial remission (PR) accounted for the percentage of patients with evaluable efficacy.

  24 months

Secondary Outcomes (4)

• disease control rate, DCR

  24 months

• Survival rate

  24 months

• Time to progress, TTP

  24 months

• Overall survival, OS

  24 months

Study Arms (2)

Idarubicin

EXPERIMENTAL

10mg idarubicin is dissolved in 5ml water for injection, and 5\~20ml lipiodol is used to prepare lipiodol emulsion.

Drug: Idarubicin Hydrochloride for Injection

Epirubicin

ACTIVE COMPARATOR

50mg epirubicin is dissolved in 5ml 5% glucose solution, and 5\~20ml lipiodol is used to prepare lipiodol emulsion.

Drug: Epirubicin

Interventions

Idarubicin Hydrochloride for Injection DRUG

After an interventional treatment, CT and/or MRI, tumor-related markers, liver and kidney function and blood routine examinations will be reviewed every 4-6 weeks, based on the patient's response to the last treatment, changes in liver function and physical fitness, and CT And (or) dynamic enhanced MRI scan to evaluate the survival of liver tumors and determine the next TACE treatment. At least 2 cycles are applied and no more than 4 cycles are applied.

Also known as: Anbijian

Idarubicin

Epirubicin DRUG

After an interventional treatment, CT and/or MRI, tumor-related markers, liver and kidney function and blood routine examinations will be reviewed every 4-6 weeks, based on the patient's response to the last treatment, changes in liver function and physical fitness, and CT And (or) dynamic enhanced MRI scan to evaluate the survival of liver tumors and determine the next TACE treatment. At least 2 cycles are applied and no more than 4 cycles are applied.

Also known as: Epirubicin Hydrochloride

Epirubicin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, no gender limit; Confirmed as hepatocellular carcinoma by histopathology or clinical diagnosis; The expected survival period is ≥3 months; Chinese liver cancer staging program (CNLC) IIb/IIIa, liver function Child pugh A or B, or Surgical resection, but due to other reasons (such as advanced age, severe liver cirrhosis, etc.) unable or unwilling to receive surgical treatment CNLC stage Ib and IIa liver cancer patients; ECOG score 0-1 points; At least one measurable lesion (spiral CT scan ≥10mm); Laboratory inspection indicators meet the following requirements: Peripheral blood: WBC≥4.0×109/L，PLT≥80×109/L，Hb≥90g/L. Renal function: Cr≤2.0×UNL (upper limit of normal); Liver function: BIL≤2.0×UNL (upper limit of normal), ALT/AST≤5.0×UNL (upper limit of normal) .

You may not qualify if:

• Have received interventional therapy for liver cancer (except cryotherapy, radio frequency and microwave); The coagulation function is severely decreased and cannot be corrected; The main portal vein is completely embolized by cancer embolism, and the formation of collateral vessels is few; Patients with active hepatitis or severe infection who cannot be treated at the same time; Patients with cachexia or multiple organ failure;Persons with uncontrollable neurological or mental diseases or mental disorders, poor compliance, unable to cooperate and describe the treatment response; primary brain tumors or central nerve metastases have not been controlled, and have obvious intracranial hypertension or neuropsychiatric symptoms ; Pregnant or lactating women; Received other clinical trial drug treatments in the past 4 weeks; Allergy to any test drug or mannitol (excipient); Other situations where the investigator believes that the patient should not participate in this trial.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Idarubicin; Injections; 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)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics; Doxorubicin

Central Study Contacts

guoliang shao

CONTACT

13958183472; Shaoguoliang666@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Randomized Controlled, Multi-center Clinical Study of Anbijian (Idarubicin Hydrochloride for Injection) vs. Epirubicin Lipiodol Emulsion Transhepatic Arterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

CN (1)