Spots Global Cancer Trial Database for Phase 2 Study of TAC-101 Combined With Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone in Japanese Patients With Advanced Hepatocellular Carcinoma
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Trial Identification
Brief Title: Phase 2 Study of TAC-101 Combined With Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone in Japanese Patients With Advanced Hepatocellular Carcinoma
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of TAC-101 in Combination With Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone in Japanese Patients With Advanced Hepatocellular Carcinoma
Study ID: NCT00667628
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether TAC-101 combined with Transcatheter Arterial Chemoembolization (TACE) is more effective than TACE alone in slowing tumor activity in patients with advanced hepatocellular carcinoma. The study is also looking at the safety of TAC-101 in combination with TACE.
Detailed Description: Advanced metastatic hepatocellular carcinoma (HCC) is not treatable by surgical approaches or locoregional therapies such as hepatic artery hemoembolization or radiofrequency ablation (RFA) which are effective in controlling localized tumors. Transcatheter arterial chemoembolization (TACE) is the most commonly performed procedure in the treatment of unresectable liver tumors for selected patients. The TACE procedure delivers highly concentrated drugs to the tumor itself and arrests blood flow. Most patients will have intrahepatic recurrence of their tumors following TACE. Studies of TAC-101, a synthetic retinoid, indicate that although TAC-101 may not induce tumor regression, it appears to have a stabilizing effect, prolonging survival over what was expected historically. This study is designed as a randomized, double-blind, placebo-controlled, parallel-group, phase 2 study in patients with advanced HCC who have undergone a TACE procedure, which will be conducted at multiple sites in Japan, to determine if administration of TAC-101 will enhance the benefits of the TACE procedure.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National hospital organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
Fukuoka University Hospital, Jonan-ku, Fukuoka, Japan
Kurume University Hospital, Kurume, Fukuoka, Japan
Ogaki Municipal Hospital, Oogaki, Gifu, Japan
Fukuyama City Hospital, Fukuyama, Hiroshima, Japan
Asahikawa-Kosei General Hospital, Asahikawa, Hokkaido, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine, Hishinomiya, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Yokohama City University Medical Center, Yokohama, Kanagawa, Japan
Mie University Hospital, Tsu, Mie, Japan
Nara Medical University Hospital, Kashihara, Nara, Japan
Okayama University Hospital, Shikata-cho, Okayama, Japan
Osaka City University Hospital, Abeno-ku, Osaka, Japan
Osaka medical Center for Cancer and Cardiovascular Diseases, Higashinari-ku, Osaka, Japan
Osaka City General Hospital, Miyakojima-ku, Osaka, Japan
Kansai Medical Univesity Takii Hospital, Moriguchi, Osaka, Japan
Kinki University Hospital, Osaka-sayama, Osaka, Japan
Osaka Red Cross Hospital, Tennoji-ku, Osaka, Japan
Shizuoka Cancer Center Hospital, Sunto-gun, Shizuoka, Japan
The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan
Tochigi Cancer Center, Chiyoda-ku, Tokyo, Japan
Kyoundo Hospital, Chiyoda, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital, Kimidera, Wakayama, Japan
Kochi Health Science Center, Kochi, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Contact Details
Name: Taiho Central, MD
Affiliation: Taiho Oncology, Inc.
Role: STUDY_DIRECTOR
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