Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: infusion group Infusion of anticancer agent followed by Embolization |
Other: Embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Infusion of anticancer agent
infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water
|
| Experimental: lipiodol chemotherapy group Infusion of mixture of anticancer agent and lipiodol followed by Embolization |
Other: Embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Infusion of mixture of anticancer agent and lipiodol
infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water
|
Outcome Measures
Primary Outcome Measures
- overall survival [3 year]
Secondary Outcome Measures
- Time to progression [3 year]
Eligibility Criteria
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.
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No serious concurrent medical illness
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Unresectable BCLC stage A-B disease
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No cirrhosis or cirrhotic status of Child-Pugh class A
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No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
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No current infections requiring antibiotic therapy
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Not on anticoagulation or suffering from a known bleeding disorder
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No unstable coronary artery disease or recent MI
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The following laboratory parameters:
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Platelet count ≥ 60,000/µL
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Hemoglobin ≥ 8.5 g/dL
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Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
-
ASL and AST ≤ 5 x upper limit of normal
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Serum creatinine ≤ 1.5 x upper limit of normal
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INR ≤ 1.5 or PT/APTT within normal limits
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Absolute neutrophil count (ANC) >1,500/mm3
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Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
-
Known history of HIV
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History of organ allograft
-
Pregnant or breast-feeding patients
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Known or suspected allergy to the investigational agents or any agent given in association with this trial.
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Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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Evidence of bleeding diathesis.
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Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
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Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
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Serious non-healing wound, ulcer, or bone fracture
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Known central nervous system tumors including metastatic brain disease
-
severe Arterioportal Shunts or Arteriavein Shunts
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Center Sun Yat-sen University | Guangzhou | Guangdong | China |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Ming Shi, MD, Cancer Center, Sun Yat-set University
Study Documents (Full-Text)
None provided.More Information
Publications
- Bruix J, Llovet JM, Castells A, Montañá X, Brú C, Ayuso MC, Vilana R, Rodés 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- HCC_S010