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

NCT ID: NCT01259414

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 812 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group1

Chemoembolization with solvent with specific gravity less than lipiodol

Group Type: EXPERIMENTAL

Solvent with specific gravity less than lipiodol

Intervention Type: OTHER

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)

group2

Chemoembolization with Solvent with specific gravity equivalent to lipiodol

Group Type: EXPERIMENTAL

Solvent with specific gravity equivalent to lipiodol

Intervention Type: OTHER

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)

Interventions

Solvent with specific gravity less than lipiodol

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

Solvent with specific gravity equivalent to lipiodol

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi

Role: PRINCIPAL_INVESTIGATOR

Cancer Center, Sun Yat-set University

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

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Reference Type: RESULT

PMID: 19721826 (View on PubMed)

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Reference Type: RESULT

PMID: 11981766 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 16250051 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18507107 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8939223 (View on PubMed)

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.

Reference Type: RESULT

PMID: 3031724 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18295692 (View on PubMed)

Other Identifiers

HCC2011A

Identifier Type: -

Identifier Source: org_study_id