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Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Idarubicin Hydrochloride for Injection
Epirubicin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-80 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) .

Exclusion Criteria:

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.

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Idarubicin

Epirubicin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

disease control rate, DCR
The number of complete remission (CR), partial remission (PR) and stable disease (SD) cases accounted for the percentage of patients with evaluable efficacy.
Survival rate
After a period of follow-up, the proportion of patients who are still alive. Observation in this study 1-year survival rate and 2-year survival rate
Time to progress, TTP
Time from start of TACE treatment to disease progression
Overall survival, OS
Time from the start of TACE treatment to death from any cause

Full Information

First Posted
September 13, 2021
Last Updated
September 13, 2021
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05053386
Brief Title
Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma
Official 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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
China is a country with a high incidence of liver cancer, the annual incidence of nearly 50% of the world. At present, transcatheter Arterial chemoembolization (TACE) has become one of the main treatment methods for primary liver cancer and liver metastasis, and has been recognized as the first choice for inoperable primary liver cancer. In addition, it has also been applied in the treatment of resectable liver cancer, liver cancer with tumor embolus and liver metastasis, which is safe and reliable. Idarubicin is a DNA topoisomerase II inhibitor that promotes DNA strand breakage, trapping cells in the G2 phase of the cell cycle, DNA cleavage, and cell apoptosis. At the same time, it can be inserted between the DNA base pairs and create freedom. Preclinical studies have shown that Idarubicin has superior antitumor activity than epirubicin, especially against SUN-449 human hepatoma cells. In recent years, foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with Idarubicin TACE, and have obtained positive results. This study aims to evaluate the safety and effectiveness of idarubicin lipiodol emulsion hepatic artery chemoembolization in the treatment of hepatocellular carcinoma, in order to provide evidence-based medical evidence for the discovery of a better TACE treatment regimen for advanced hepatocellular carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Idarubicin
Arm Type
Experimental
Arm Description
10mg idarubicin is dissolved in 5ml water for injection, and 5~20ml lipiodol is used to prepare lipiodol emulsion.
Arm Title
Epirubicin
Arm Type
Active Comparator
Arm Description
50mg epirubicin is dissolved in 5ml 5% glucose solution, and 5~20ml lipiodol is used to prepare lipiodol emulsion.
Intervention Type
Drug
Intervention Name(s)
Idarubicin Hydrochloride for Injection
Other Intervention Name(s)
Anbijian
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
Epirubicin Hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate, ORR
Description
The number of cases that achieved complete remission (CR) or partial remission (PR) accounted for the percentage of patients with evaluable efficacy.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
disease control rate, DCR
Description
The number of complete remission (CR), partial remission (PR) and stable disease (SD) cases accounted for the percentage of patients with evaluable efficacy.
Time Frame
24 months
Title
Survival rate
Description
After a period of follow-up, the proportion of patients who are still alive. Observation in this study 1-year survival rate and 2-year survival rate
Time Frame
24 months
Title
Time to progress, TTP
Description
Time from start of TACE treatment to disease progression
Time Frame
24 months
Title
Overall survival, OS
Description
Time from the start of TACE treatment to death from any cause
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 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) . Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
guoliang shao
Phone
13958183472
Email
Shaoguoliang666@hotmail.com
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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Idarubicin vs. Epirubicin TACE in the Treatment of Hepatocellular Carcinoma

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