Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-cancer agent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epirubicin | Drug | Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | 6 months |
Not provided
Not provided
Inclusion Criteria:
Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions.
Subject must to be the first experience of TACE.
Subject has no extra-hepatic tumor and no obstruction of main portal vein.
Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).
ECOG performance status 0-2
Child-pugh Class A or B
Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below:
Written informed consent
Exclusion Criteria:
Subject has extra hepatic metastasis.
Tumor thrombosis exists at main portal vein.
Remarkable artery-portal vein shunt or veno-arterial shunt.
Uncontrollable ascites or pleural effusion.
History of severe hypersensitivity.
Any previous TACE or TAE for HCC.
Any previous chemotherapy using epirubicin or CDDP.
Complications as below (except chronic hepatitis or liver cirrhosis)
Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.
Any subject judged by the investigator to be unfit for any reason to participate in the study.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Masashi Fujii, MD | Contact | +81332981711 | masashi.fujii@gioncology.jp | |
| Tadatoshi Takayama, MD | Contact | +81339728111 | Takayama.Tadatoshi@nihon-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Tadatoshi Takayama, M.D. | Digestive Surgery Nihon University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Digestive Surgery, Nihon University School of Medicine | Recruiting | tabashi City | Tokyo | 173-8610 | Japan |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Cisplatin | Drug | Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively. |
|
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |