- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05280444
Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma
Transarterial Chemoembolization With Lipiodol-Idarubicin Emulsion in the Treatment of Hepatocellular Carcinoma: a Prospective, Multicenter, Real-world Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Hai-Dong Zhu, MD
- Phone Number: +86-02583272121
- Email: zhuhaidong9509@163.com
Study Contact Backup
- Name: Gao-Jun Teng, MD
- Phone Number: +86-02583272121
- Email: gjteng@vip.sina.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- Zhongda Hospital, Southeast University
-
Contact:
- Hai-Dong Zhu, MD
- Phone Number: +86-02583272121
- Email: zhuhaidong9509@163.com
-
Contact:
- Gao-Jun Teng, MD
- Phone Number: +86 25 83272121
- Email: gjteng@seu.edu.cn
-
Principal Investigator:
- Gao-Jun Teng, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lipiodol-TACE with Idarubicin
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate(ORR)
Time Frame: Up to approximately 2 years
|
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) [mRECIST].
|
Up to approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate(DCR)
Time Frame: Up to approximately 2 years
|
The DCR is defined as the percentage of participants who have the overall response of CR, PR, or stable disease (SD) [mRECIST].
|
Up to approximately 2 years
|
Time to Progression(TTP)
Time Frame: Up to approximately 2 years
|
The TTP is defined as the time from the initiation TACE to tumor progression [mRECIST].
|
Up to approximately 2 years
|
Overall Survival(OS)
Time Frame: Up to approximately 2 years
|
The OS is defined as the time from the initiation TACE to death from any cause.
|
Up to approximately 2 years
|
Survival Rate
Time Frame: Up to approximately 2 years
|
The proportion of patients who are still alive during the follw-up period.
|
Up to approximately 2 years
|
Adverse Events(AEs)
Time Frame: Up to approximately 2 years
|
Incidence and severity of adverse events.
|
Up to approximately 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gao-Jun Teng, MD, Zhongda hospital, Southeast university, Nanjing, China
Publications and helpful links
General Publications
- Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
- Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.
- Camma C, Schepis F, Orlando A, Albanese M, Shahied L, Trevisani F, Andreone P, Craxi A, Cottone M. Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials. Radiology. 2002 Jul;224(1):47-54. doi: 10.1148/radiol.2241011262.
- Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.
- Tang A, Hallouch O, Chernyak V, Kamaya A, Sirlin CB. Epidemiology of hepatocellular carcinoma: target population for surveillance and diagnosis. Abdom Radiol (NY). 2018 Jan;43(1):13-25. doi: 10.1007/s00261-017-1209-1.
- Bruix J, Gores GJ, Mazzaferro V. Hepatocellular carcinoma: clinical frontiers and perspectives. Gut. 2014 May;63(5):844-55. doi: 10.1136/gutjnl-2013-306627. Epub 2014 Feb 14.
- Lencioni R, de Baere T, Soulen MC, Rilling WS, Geschwind JF. Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data. Hepatology. 2016 Jul;64(1):106-16. doi: 10.1002/hep.28453. Epub 2016 Mar 7.
- Pelletier G, Ducreux M, Gay F, Luboinski M, Hagege H, Dao T, Van Steenbergen W, Buffet C, Rougier P, Adler M, Pignon JP, Roche A. Treatment of unresectable hepatocellular carcinoma with lipiodol chemoembolization: a multicenter randomized trial. Groupe CHC. J Hepatol. 1998 Jul;29(1):129-34. doi: 10.1016/s0168-8278(98)80187-6.
- Boulin M, Guiu S, Chauffert B, Aho S, Cercueil JP, Ghiringhelli F, Krause D, Fagnoni P, Hillon P, Bedenne L, Guiu B. Screening of anticancer drugs for chemoembolization of hepatocellular carcinoma. Anticancer Drugs. 2011 Sep;22(8):741-8. doi: 10.1097/CAD.0b013e328346a0c5.
- Favelier S, Boulin M, Hamza S, Cercueil JP, Cherblanc V, Lepage C, Hillon P, Chauffert B, Krause D, Guiu B. Lipiodol trans-arterial chemoembolization of hepatocellular carcinoma with idarubicin: first experience. Cardiovasc Intervent Radiol. 2013 Aug;36(4):1039-46. doi: 10.1007/s00270-012-0532-8. Epub 2012 Dec 8.
- Tavernier J, Fagnoni P, Chabrot P, Guiu B, Vadot L, Aho S, Boyer L, Abergel A, Hillon P, Sautou V, Boulin M. Comparison of two transarterial chemoembolization strategies for hepatocellular carcinoma. Anticancer Res. 2014 Dec;34(12):7247-53.
- Boulin M, Schmitt A, Delhom E, Cercueil JP, Wendremaire M, Imbs DC, Fohlen A, Panaro F, Herrero A, Denys A, Guiu B. Improved stability of lipiodol-drug emulsion for transarterial chemoembolisation of hepatocellular carcinoma results in improved pharmacokinetic profile: Proof of concept using idarubicin. Eur Radiol. 2016 Feb;26(2):601-9. doi: 10.1007/s00330-015-3855-4. Epub 2015 Jun 11.
- Guiu B, Jouve JL, Schmitt A, Minello A, Bonnetain F, Cassinotto C, Piron L, Cercueil JP, Loffroy R, Latournerie M, Wendremaire M, Lepage C, Boulin M. Intra-arterial idarubicin_lipiodol without embolisation in hepatocellular carcinoma: The LIDA-B phase I trial. J Hepatol. 2018 Jun;68(6):1163-1171. doi: 10.1016/j.jhep.2018.01.022. Epub 2018 Feb 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Idarubicin
Other Study ID Numbers
- CHANCE-2006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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