Transarterial Chemoembolization With or Without Lipiodol in Patient With Unresectable Hepatocellular Carcinoma
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Purpose
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 lipiodol can achieve a better survival but less side effects for advanced stage HCC. Thus, the investigators carried out this prospective control study to find out if the survivals for patients after TACE without lipiodol better than TACE with an emulsion of anticancer drugs in lipiodol.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Other: Procedure:Transarterial chemoembolization (TACE) Other: Procedure/Surgery: Transarterial chemoembolization (TACE) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial. |
- overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 379 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: infusion group
chemotherapy drugs infusion followed embolization with polyvinyl alcohol particles (PVA)
|
Other: Procedure:Transarterial chemoembolization (TACE)
drugs and dosage:TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)and followed embolization with polyvinyl alcohol particles (PVA)
|
|
Experimental: lipiodol chemotherapy group
Injection of chemotherapy drugs mixed with iodized oil lipidol (10ml) followed embolization with polyvinyl alcohol particles (PVA)
|
Other: Procedure/Surgery: Transarterial chemoembolization (TACE)
drugs and dosage:TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol (10ml) and final embolization with polyvinyl alcohol particles (PVA).
|
Detailed Description:
TACE is the most widely used therapy in patients with HCC who are considered to be unsuitable candidates for curative therapy.And the regimen of TACE with anticancer agents and followed embolic particles has become a standard treatment for unresectable hepatocellular carcinoma. However, there are variety TACE protocols with different chemotherapeutic agents（combined or alone）,which mixed with lipiodol or not,different embolic agents(temporary or permanent ) and how these drugs combine. Currently, no standard protocol exists for TACE. One of the controversy is what's the mechanism of lipiodol. This disparity in the literature is the effectiveness of the lipiodol is unclear: some study reveal a regimen contain lipiodol can improves survival ,while the other research consider there is no any statistical significances in survival,but also aggravate the side effects. Thus , The purpose of the investigators' study is to prospectively study the efficacy of lipiodol in transcatheter arterial Chemoembolization with two kinds of regimens for nonresectable hepatocellular carcinoma based on multivariate analysis of prognostic factors. The study had a interim analysis to allow the trial to be stopped if significant differences were detected. The accumulated data were examined when half patient was enrolled in the clinical trial.
Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion, we study the differences of survival between two regimens of transcatheter arterial Chemoembolization.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Eligibility criteria:1-Inclusion Criteria；Inclusion Criteria:
- Male or female patients > 18 years and <=70 years of age with a diagnosis of HCC
- Adults patients with a diagnosis of HCC which is not amenable to surgical resection ,local ablative therapy and any other cured treatment.
- A diagnosis of HCC based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- The patient has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria
- No serious concurrent medical illness
- Unresectable BCLC stage B disease
- Not pregnant or breast-feeding patients
- Cirrhotic status of Child-Pugh class A only
- 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
- 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
Contacts and Locations| Contact: Ming Shi, MD | 86-2087343582 ext 86-2087343582 | shiming@mail.sysu.edu.cn |
| Contact: Rong Ping Guo, MD | 86-2087343117 ext 86-2087343117 | guorongp@mail.sysu.edu.cn |
| China, Guangdong | |
| Cancer Center Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Ming Shi, MD 86-2087343582 ext 86-2087343582 shiming@mail.sysu.edu.cn | |
| Contact: Rong Ping Guo, MD 86-2087343117 ext 86-2087343117 guorongp@mail.sysu.edu.cn | |
| Principal Investigator: Ming Shi, MD | |
| Principal Investigator: | Ming Shi, MD | Cancer Center, Sun Yat-set University |
More Information
Publications:
| Responsible Party: | Shi Ming, Professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01229839 History of Changes |
| Other Study ID Numbers: | HCC008010 |
| Study First Received: | October 25, 2010 |
| Last Updated: | June 18, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-sen University:
|
Carcinoma,Hepatocellular Liver Neoplasms Therapeutic Chemoembolization, TACE |
pharmacokinetics Iodized Oil/administration & dosage polyvinyl alcohol Humans |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Ethiodized Oil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013