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Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Solvent with specific gravity less than lipiodol

Solvent with specific gravity equivalent to lipiodol

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Carcinoma,Hepatocellular, Liver Neoplasms, Survival analysis, treatment outcome, administration drugs, Chemoembolization,, TACE, polyvinyl alcohol, water-soluble contrast mesium, iopamidol, lipiodol, distilled water

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients > 18 years and <=70 years of age with a diagnosis of HCC
BCLC B stage disease
Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. The lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
No Cirrhosis or cirrhotic status of Child-Pugh class A only
Not pregnant or breast-feeding patients
No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
The following laboratory parameters:
- Platelet count ≥ 60,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
- ASL and AST ≤ 5 x upper limit of normal
- Serum creatinine ≤ 1.5 x upper limit of normal
- INR ≤ 1.5 or PT/APTT within normal limits
- Absolute neutrophil count (ANC) >1,500/mm3
Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

Known history of HIV
History of organ allograft
Known or suspected allergy to the investigational agents or any agent given in association with this trial.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Evidence of bleeding diathesis.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Serious non-healing wound, ulcer, or bone fracture
Known central nervous system tumors including metastatic brain disease
severe Arterioportal Shunts or Arteria vein Shunts

Sites / Locations

Cancer Center Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

group1

group2

Arm Description

Chemoembolization with solvent with specific gravity less than lipiodol

Chemoembolization with Solvent with specific gravity equivalent to lipiodol

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Time to progression

Full Information

NCT ID

NCT01259414

First Posted

December 13, 2010

Last Updated

March 5, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01259414

Brief Title

Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma

Official Title

Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

TACE is considered the standard treatment for unresectable HCC and is widely used as a palliative treatment. However there is no consensus of the protocol of TACE.One of the variation is does the stability of the suspension by emulsified the lipiodol and the contrast medium used to dissolve the anticancer agents really effect the survival.Thus the investigators conduct this prospective,randomized controlled study to find out if the different method of preparing chemotheraputic drugs can cause a different survival benefit.

Detailed Description

Transcatheter arterial chemoembolization is currently the mainstays of palliative treatments worldwide for patients with unresectable HCC. However there is no standard protocol exists for TACE currently. One of the controversy is does the way of emulsified the anticancer agents and lipiodol to get a high stability suspension really effect the survival rates. Anticancer drugs play important role in survival benefit. Many studies have innovated different methods to get a high stability suspension of lipiodol and anticancer drugs ,because they think lipiodol can selectively retained in HCC and used as a drug-carrying which allow a slow release of the anticancer drug from lipiodol microdroplets. Thus ,A stability suspension might get a maximize tumor drug uptake,which can caused a more tumor necrosis, and minimize systemic drug levels ,which get a less toxicity, hence survival benefit. While the other researcher think a stability emulsion can't get a positive effect ,such as pharmacokinetic and systematic toxicity of the anticancer drugs, tumor response, biologic response and so on.

6. Conditions and Keywords

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

Hepatocellular Carcinoma

Keywords

Carcinoma,Hepatocellular, Liver Neoplasms, Survival analysis, treatment outcome, administration drugs, Chemoembolization,, TACE, polyvinyl alcohol, water-soluble contrast mesium, iopamidol, lipiodol, distilled water

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

812 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group1

Arm Type

Experimental

Arm Description

Chemoembolization with solvent with specific gravity less than lipiodol

Arm Title

group2

Arm Type

Experimental

Arm Description

Chemoembolization with Solvent with specific gravity equivalent to lipiodol

Intervention Type

Other

Intervention Name(s)

Solvent with specific gravity less than lipiodol

Intervention Description

TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in distilled water and emulsified lipiodol followed embolization with polyvinyl alcohol particles (PVA)

Intervention Type

Other

Intervention Name(s)

Solvent with specific gravity equivalent to lipiodol

Intervention Description

TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water,then emulsified with lipiodol followed embolization with polyvinyl alcohol particles (PVA)

Primary Outcome Measure Information:

Title

overall survival

Time Frame

3 year

Secondary Outcome Measure Information:

Title

Time to progression

Time Frame

3 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients > 18 years and <=70 years of age with a diagnosis of HCC BCLC B stage disease Not amendable to surgical resection ,local ablative therapy and any other cured treatment. Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. The lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. No Cirrhosis or cirrhotic status of Child-Pugh class A only Not pregnant or breast-feeding patients No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis The following laboratory parameters: Platelet count ≥ 60,000/µL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: Known history of HIV History of organ allograft Known or suspected allergy to the investigational agents or any agent given in association with this trial. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug Serious non-healing wound, ulcer, or bone fracture Known central nervous system tumors including metastatic brain disease severe Arterioportal Shunts or Arteria vein Shunts

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Shi

Organizational Affiliation

Cancer Center, Sun Yat-set University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

19721826

Citation

Shin SW. The current practice of transarterial chemoembolization for the treatment of hepatocellular carcinoma. Korean J Radiol. 2009 Sep-Oct;10(5):425-34. doi: 10.3348/kjr.2009.10.5.425. Epub 2009 Aug 25.

Results Reference

result

PubMed Identifier

11981766

Citation

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.

Results Reference

result

PubMed Identifier

12049862

Citation

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.

Results Reference

result

PubMed Identifier

1320447

Citation

Raoul JL, Heresbach D, Bretagne JF, Ferrer DB, Duvauferrier R, Bourguet P, Messner M, Gosselin M. Chemoembolization of hepatocellular carcinomas. A study of the biodistribution and pharmacokinetics of doxorubicin. Cancer. 1992 Aug 1;70(3):585-90. doi: 10.1002/1097-0142(19920801)70:33.0.co;2-#.

Results Reference

result

PubMed Identifier

16250051

Citation

Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

Results Reference

result

PubMed Identifier

18507107

Citation

Takaki Y, Kaminou T, Shabana M, Ihaya T, Otsubo K, Ogawa T. Suitable blending method of lipiodol-cisplatin in transcatheter arterial embolization for hepatocellular carcinoma: evaluation of sustained release and accumulation nature. Hepatogastroenterology. 2008 Jan-Feb;55(81):202-6.

Results Reference

result

PubMed Identifier

8939223

Citation

de Baere T, Zhang X, Aubert B, Harry G, Lagrange C, Ropers J, Dufaux J, Lumbroso J, Rougier P, Ducreux M, Roche A. Quantification of tumor uptake of iodized oils and emulsions of iodized oils: experimental study. Radiology. 1996 Dec;201(3):731-5. doi: 10.1148/radiology.201.3.8939223.

Results Reference

result

PubMed Identifier

3031724

Citation

Takayasu K, Shima Y, Muramatsu Y, Moriyama N, Yamada T, Makuuchi M, Hasegawa H, Hirohashi S. Hepatocellular carcinoma: treatment with intraarterial iodized oil with and without chemotherapeutic agents. Radiology. 1987 May;163(2):345-51. doi: 10.1148/radiology.163.2.3031724.

Results Reference

result

PubMed Identifier

18295692

Citation

Tzeng WS, Wu RH, Chang SC, Chou CK, Lin CY, Chen JJ, Yang SC, Lin CH. Ionic versus nonionic contrast media solvents used with an epirubicin-based agent for transarterial chemoembolization of hepatocellular carcinoma. J Vasc Interv Radiol. 2008 Mar;19(3):342-50. doi: 10.1016/j.jvir.2007.10.021.

Results Reference

result

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Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma

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