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Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Idarubicin Hydrochloride for Injection
Sponsored by
Zhongda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Transarterial chemoembolization, Idarubicin, Real-world study

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1).18-75 years old; no gender limit; 2).Confirmed diagnosis of HCC according to histopathology or CNLC guidelines (2019 Edition); 3)Life expectancy≥3 months; 4).Child-Pugh class A or B; 5).ECOG PS of 0 or 1;6).One of the following cases: CNLC stage IIb and IIIa; CNLC stage Ib and IIa patient who is unable or unwilling to receive surgical treatment due to other reasons (such as advanced age, severe liver cirrhosis, etc.); The main portal vein has not been completely obstructed, with abundant collateral vessels, or restore the blood flow by portal vein stent placement; 7). At least one measurable lesion (the length diameter≥10mm); 8).Laboratory indices: WBC≥3.0×109/L; PLT≥50×109/L; Hb≥70g/L; Cr≤1.5×UNL(upper limit of normal); BIL≤2.0×UNL, ALT≤5.0×UNL, AST≤5.0×UNL.

Exclusion Criteria:

1).The coagulation function is severely decreased and cannot be recovered; 2).The main portal vein is completely embolized by cancer embolism, with few collateral vessels; 3).With active hepatitis or severe infection that cannot be treated at the same time; 4). With cachexia or multiple organ failure; 5). With uncontrollable neurological and mental disorders, or poor compliance; 6.) Primary brain tumors or central nervous system metastasis has not been controlled, with obvious intracranial hypertension or neuropsychiatric symptoms; 7). Pregnant or breast feeding women; 8). Received drug treatments in other clinical trial in the past 4 weeks; 9). Other situations where the investigators judge that the patient should not participate in.

Sites / Locations

  • Zhongda Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lipiodol-TACE with Idarubicin

Arm Description

The initial dose of idarubicin is 10 mg and the maximum tolerated dose is 20 mg. Idarubicin is first dissolved in water for injection to make a solvent of 2mg/ml, which is then mixed with lipiodol to make an emulsion with a ratio of 1:2. Lipiodol-idarubicin emulsion is slowly injected, followed by embolization with embolic agents.

Outcomes

Primary Outcome Measures

Objective Response Rate(ORR)
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) [mRECIST].

Secondary Outcome Measures

Disease Control Rate(DCR)
The DCR is defined as the percentage of participants who have the overall response of CR, PR, or stable disease (SD) [mRECIST].
Time to Progression(TTP)
The TTP is defined as the time from the initiation TACE to tumor progression [mRECIST].
Overall Survival(OS)
The OS is defined as the time from the initiation TACE to death from any cause.
Survival Rate
The proportion of patients who are still alive during the follw-up period.
Adverse Events(AEs)
Incidence and severity of adverse events.

Full Information

First Posted
March 11, 2022
Last Updated
December 28, 2022
Sponsor
Zhongda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05280444
Brief Title
Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma
Official Title
Transarterial Chemoembolization With Lipiodol-Idarubicin Emulsion in the Treatment of Hepatocellular Carcinoma: a Prospective, Multicenter, Real-world Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this real-world study is to evaluate the safety and efficacy of lipiodol-TACE with idarubicin for hepatocellular carcinoma.
Detailed Description
Idarubicin is a DNA topoisomerase II inhibitor that promotes DNA strand breakage, trapping cells in the G2 phase of the cell cycle and inducing DNA cleavage and cell apoptosis. At the same time, it can be inserted between the DNA base pairs and produce free radicals, thus breaking the DNA double helix structure and inhibiting the extension, replication and transcription of DNA strands. Preclinical studies have shown that idarubicin has higher antitumor activity than epirubicin, especially against SUN-449 human hepatoma cells. In recent years, domestic and foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with lipiodol-idarubicin emulsion, and have obtained positive results. This proepective, multicenter real-worldstudy aims to evaluate the efficacy and safety of lipiodol-TACE with idarubicin in Chinese HCC patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Transarterial chemoembolization, Idarubicin, Real-world study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lipiodol-TACE with Idarubicin
Arm Type
Experimental
Arm Description
The initial dose of idarubicin is 10 mg and the maximum tolerated dose is 20 mg. Idarubicin is first dissolved in water for injection to make a solvent of 2mg/ml, which is then mixed with lipiodol to make an emulsion with a ratio of 1:2. Lipiodol-idarubicin emulsion is slowly injected, followed by embolization with embolic agents.
Intervention Type
Drug
Intervention Name(s)
Idarubicin Hydrochloride for Injection
Other Intervention Name(s)
Anbijian
Intervention Description
The initial dose of idarubicin is 10 mg and the maximum tolerated dose is 20 mg. Idarubicin is first dissolved in water for injection to make a solvent of 2mg/ml, which is then mixed with lipiodol to make an emulsion with a ratio of 1:2. Lipiodol-idarubicin emulsion is slowly injected, followed by embolization with embolic agents.
Primary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) [mRECIST].
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Disease Control Rate(DCR)
Description
The DCR is defined as the percentage of participants who have the overall response of CR, PR, or stable disease (SD) [mRECIST].
Time Frame
Up to approximately 2 years
Title
Time to Progression(TTP)
Description
The TTP is defined as the time from the initiation TACE to tumor progression [mRECIST].
Time Frame
Up to approximately 2 years
Title
Overall Survival(OS)
Description
The OS is defined as the time from the initiation TACE to death from any cause.
Time Frame
Up to approximately 2 years
Title
Survival Rate
Description
The proportion of patients who are still alive during the follw-up period.
Time Frame
Up to approximately 2 years
Title
Adverse Events(AEs)
Description
Incidence and severity of adverse events.
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1).18-75 years old; no gender limit; 2).Confirmed diagnosis of HCC according to histopathology or CNLC guidelines (2019 Edition); 3)Life expectancy≥3 months; 4).Child-Pugh class A or B; 5).ECOG PS of 0 or 1;6).One of the following cases: CNLC stage IIb and IIIa; CNLC stage Ib and IIa patient who is unable or unwilling to receive surgical treatment due to other reasons (such as advanced age, severe liver cirrhosis, etc.); The main portal vein has not been completely obstructed, with abundant collateral vessels, or restore the blood flow by portal vein stent placement; 7). At least one measurable lesion (the length diameter≥10mm); 8).Laboratory indices: WBC≥3.0×109/L; PLT≥50×109/L; Hb≥70g/L; Cr≤1.5×UNL(upper limit of normal); BIL≤2.0×UNL, ALT≤5.0×UNL, AST≤5.0×UNL. Exclusion Criteria: 1).The coagulation function is severely decreased and cannot be recovered; 2).The main portal vein is completely embolized by cancer embolism, with few collateral vessels; 3).With active hepatitis or severe infection that cannot be treated at the same time; 4). With cachexia or multiple organ failure; 5). With uncontrollable neurological and mental disorders, or poor compliance; 6.) Primary brain tumors or central nervous system metastasis has not been controlled, with obvious intracranial hypertension or neuropsychiatric symptoms; 7). Pregnant or breast feeding women; 8). Received drug treatments in other clinical trial in the past 4 weeks; 9). Other situations where the investigators judge that the patient should not participate in.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao-Jun Teng, MD
Phone
+86-02583272121
Email
gjteng@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hai-Dong Zhu, MD
Phone
+86-02583272121
Email
zhuhaidong9509@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Organizational Affiliation
Zhongda hospital, Southeast university, Nanjing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Phone
+86 25 83272121
Email
gjteng@seu.edu.cn
First Name & Middle Initial & Last Name & Degree
Hai-Dong Zhu, MD
Phone
+86-02583272121
Email
zhuhaidong9509@163.com
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma

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