Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma

NCT05280444 | Unknown Phase 2

• 1 other identifier: CHANCE-2006
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this real-world study is to evaluate the safety and efficacy of lipiodol-TACE with idarubicin for hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Transarterial chemoembolization; Idarubicin; Real-world study

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  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 Outcomes (5)

• Disease Control Rate(DCR)

  Up to approximately 2 years

• Time to Progression(TTP)

  Up to approximately 2 years

• Overall Survival(OS)

  Up to approximately 2 years

• Survival Rate

  Up to approximately 2 years

• Adverse Events(AEs)

  Up to approximately 2 years

Study Arms (1)

Lipiodol-TACE with Idarubicin

EXPERIMENTAL

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.

Drug: Idarubicin Hydrochloride for Injection

Interventions

Idarubicin Hydrochloride for Injection DRUG

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.

Also known as: Anbijian

Lipiodol-TACE with Idarubicin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ).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.

You may not qualify if:

• ).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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (13)

• 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.

  PMID: 28647765 RESULT

• 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.

  PMID: 24531850 RESULT

• 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.

  PMID: 26765068 RESULT

• 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.

  PMID: 9696501 RESULT

• 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.

  PMID: 11981766 RESULT

• 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.

  PMID: 12049862 RESULT

• 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.

  PMID: 12091661 RESULT

• 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.

  PMID: 12540794 RESULT

• 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.

  PMID: 21487286 RESULT

• 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.

  PMID: 23224215 RESULT

• 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.

  PMID: 25503156 RESULT

• 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.

  PMID: 26060065 RESULT

• 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.

  PMID: 29427728 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Idarubicin; Injections

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

Study Officials

• Gao-Jun Teng, MD

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, MD

CONTACT

+86-02583272121; gjteng@vip.sina.com

Hai-Dong Zhu, MD

CONTACT

+86-02583272121; zhuhaidong9509@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 15, 2022
• Study Start: May 28, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)