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

NCT01229839 | Completed Phase 3 DMC

• 1 other identifier: HCC_S010
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Carcinoma,Hepatocellular; Liver Neoplasms; Therapeutic; Chemoembolization,; TACE; pharmacokinetics; Iodized Oil/administration & dosage; polyvinyl alcohol; Humans

Outcome Measures

Primary Outcomes (1)

• overall survival

  3 year

Secondary Outcomes (1)

• Time to progression

  3 year

Study Arms (2)

infusion group

EXPERIMENTAL

Infusion of anticancer agent followed by Embolization

Other: Embolization; Other: Infusion of anticancer agent

lipiodol chemotherapy group

EXPERIMENTAL

Infusion of mixture of anticancer agent and lipiodol followed by Embolization

Other: Embolization; Other: Infusion of mixture of anticancer agent and lipiodol

Interventions

Embolization OTHER

embolization with lipiodol and polyvinyl alcohol particles (PVA)

infusion group; lipiodol chemotherapy group

Infusion of anticancer agent OTHER

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

infusion group

Infusion of mixture of anticancer agent and lipiodol OTHER

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

lipiodol chemotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (7)

• 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 BACKGROUND

• 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.

  PMID: 10751477 BACKGROUND

• 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.

  PMID: 10215657 BACKGROUND

• 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.

  PMID: 8244149 BACKGROUND

• 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.

  PMID: 9620330 BACKGROUND

• 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.

  PMID: 10655437 BACKGROUND

• 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.

  PMID: 11202797 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Embolization, Therapeutic; Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Ming Shi, MD

  Cancer Center, Sun Yat-set University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 28, 2010
• Study Start: August 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

CN (1)