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Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Embolization

Infusion of anticancer agent

Infusion of mixture of anticancer agent and lipiodol

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Carcinoma,Hepatocellular, Liver Neoplasms, Therapeutic, Chemoembolization,, TACE, pharmacokinetics, Iodized Oil/administration & dosage, polyvinyl alcohol, Humans

Eligibility Criteria

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

Eligibility criteria:

Inclusion Criteria:

Adults patients with a diagnosis of HCC which is not amenable 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. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
No serious concurrent medical illness
Unresectable BCLC stage A-B disease
No cirrhosis or cirrhotic status of Child-Pugh class A
No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
No current infections requiring antibiotic therapy
Not on anticoagulation or suffering from a known bleeding disorder
No unstable coronary artery disease or recent MI
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
Pregnant or breast-feeding patients
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 Arteriavein Shunts

Sites / Locations

Cancer Center Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

infusion group

lipiodol chemotherapy group

Arm Description

Infusion of anticancer agent followed by Embolization

Infusion of mixture of anticancer agent and lipiodol followed by Embolization

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Time to progression

Full Information

NCT ID

NCT01229839

First Posted

October 25, 2010

Last Updated

March 5, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01229839

Brief Title

Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

Official Title

Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Mixing the Chemotherapy With Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (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 on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.

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, Therapeutic, Chemoembolization,, TACE, pharmacokinetics, Iodized Oil/administration & dosage, polyvinyl alcohol, Humans

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

668 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

infusion group

Arm Type

Experimental

Arm Description

Infusion of anticancer agent followed by Embolization

Arm Title

lipiodol chemotherapy group

Arm Type

Experimental

Arm Description

Infusion of mixture of anticancer agent and lipiodol followed by Embolization

Intervention Type

Other

Intervention Name(s)

Embolization

Intervention Description

embolization with lipiodol and polyvinyl alcohol particles (PVA)

Intervention Type

Other

Intervention Name(s)

Infusion of anticancer agent

Intervention Description

infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water

Intervention Type

Other

Intervention Name(s)

Infusion of mixture of anticancer agent and lipiodol

Intervention Description

infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water

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

Eligibility criteria: Inclusion Criteria: Adults patients with a diagnosis of HCC which is not amenable 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. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. No serious concurrent medical illness Unresectable BCLC stage A-B disease No cirrhosis or cirrhotic status of Child-Pugh class A No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis No current infections requiring antibiotic therapy Not on anticoagulation or suffering from a known bleeding disorder No unstable coronary artery disease or recent MI 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 Pregnant or breast-feeding patients 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 Arteriavein Shunts

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Shi, MD

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

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

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PubMed Identifier

10751477

Citation

Caturelli E, Siena DA, Fusilli S, Villani MR, Schiavone G, Nardella M, Balzano S, Florio F. Transcatheter arterial chemoembolization for hepatocellular carcinoma in patients with cirrhosis: evaluation of damage to nontumorous liver tissue-long-term prospective study. Radiology. 2000 Apr;215(1):123-8. doi: 10.1148/radiology.215.1.r00ap21123.

Results Reference

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PubMed Identifier

10215657

Citation

Higashi S, Tabata N, Kondo KH, Maeda Y, Shimizu M, Nakashima T, Setoguchi T. Size of lipid microdroplets effects results of hepatic arterial chemotherapy with an anticancer agent in water-in-oil-in-water emulsion to hepatocellular carcinoma. J Pharmacol Exp Ther. 1999 May;289(2):816-9.

Results Reference

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PubMed Identifier

8244149

Citation

Madden MV, Krige JE, Bailey S, Beningfield SJ, Geddes C, Werner ID, Terblanche J. Randomised trial of targeted chemotherapy with lipiodol and 5-epidoxorubicin compared with symptomatic treatment for hepatoma. Gut. 1993 Nov;34(11):1598-600. doi: 10.1136/gut.34.11.1598.

Results Reference

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PubMed Identifier

9620330

Citation

Bruix J, Llovet JM, Castells A, Montana X, Bru C, Ayuso MC, Vilana R, Rodes J. Transarterial embolization versus symptomatic treatment in patients with advanced hepatocellular carcinoma: results of a randomized, controlled trial in a single institution. Hepatology. 1998 Jun;27(6):1578-83. doi: 10.1002/hep.510270617.

Results Reference

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PubMed Identifier

10655437

Citation

Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

Results Reference

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PubMed Identifier

11202797

Citation

Ono Y, Yoshimasu T, Ashikaga R, Inoue M, Shindou H, Fuji K, Araki Y, Nishimura Y. Long-term results of lipiodol-transcatheter arterial embolization with cisplatin or doxorubicin for unresectable hepatocellular carcinoma. Am J Clin Oncol. 2000 Dec;23(6):564-8. doi: 10.1097/00000421-200012000-00006.

Results Reference

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Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

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