Clinical Trials List
2011-03-01 - 2016-06-30
Phase III
Terminated14
ICD-10C22.9
Malignant neoplasm of liver, not specified as primary or secondary
A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
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Sponsor
Taiho Pharmaceutical Co., Ltd.,
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chung-Pin Li Digestive System Department
- Chien-Wei Su Digestive System Department
- Yi-Hsiang Huang Digestive System Department
- Rheun-Chuan Lee Division of Radiology
- 邱怡友 Division of Radiology
- 曾修山 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 柯忠旺 Digestive System Department
- 呂宜達 Digestive System Department
- 葉宏仁 Digestive System Department
- 廖思嘉 Digestive System Department
- Sheng-Shun Yang Digestive System Department
- 黃振義 Division of Radiology
- TENG-YU LEE Digestive System Department
- 李少武 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Cheng-Yuan Peng Digestive System Department
- 蘇文邦 Digestive System Department
- 陳永芳 Division of Radiology
- Po-Heng Chuang Digestive System Department
- 高榮達 Digestive System Department
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳威宇 Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 馮盈勳 Division of Hematology & Oncology
- 林明賢 Division of Hematology & Oncology
- Shang-Wen Chen Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wen-Juei Jeng Digestive System Department
- 呂嘉偉 Division of Radiology
- Chun-Yen Lin Digestive System Department
- Chien-Hao Huang Digestive System Department
- 林宗男 Digestive System Department
- 林淳榮 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 胡琮輝 Digestive System Department
- 郭垣宏 Digestive System Department
- 洪肇宏 Digestive System Department
- 顏毅豪 Digestive System Department
- Jing-Houng Wang Digestive System Department
- 陳建宏 Digestive System Department
- 陳泰益 Division of Radiology
- 盧勝男 Digestive System Department
- 張國欽 Digestive System Department
- 曾柏霖 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Shinn-Cherng Chen Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳毅晉 Digestive System Department
- Pin-Nan Cheng Digestive System Department
- Chia-Jui Yen Division of Hematology & Oncology
- Yih-Jyh Lin Division of General Surgery
- Li-Tzong Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chien-Hung Chen Digestive System Department
- Ying-Chun Shen Division of Hematology & Oncology
- 李伯皇 Division of Radiology
- Chiun Hsu Division of Hematology & Oncology
- JA-DER LIANG Digestive System Department
- - - Division of Radiology
- Ming-Chih Ho Division of General Surgery
- REY-HENG HU Division of General Surgery
- PEI-JER CHEN Digestive System Department
- Chih-Hung Hsu Division of Hematology & Oncology
- 吳志宏 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Overall Survival(OS) [ Time Frame: The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient ]
Secondary Outcome Measures :
Time to Transcatheter Arterial Chemoembolization (TACE) Failure [ Time Frame: The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient ]
Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.
The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE
Deterioration in arterial pathways to treat HCC that makes additional TACE impossible
Severe vascular invasion occurs that makes additional TACE impossible
Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC
Liver function at grade Child-Pugh class C lasting for 28 days
Inclution Criteria
Patients must be diagnosed as HCC.
Patients has no indications for treatment with curative hepatic resection or curative percutaneous local therapy.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Patients are able to receive oral medication.
Exclusion Criteria
The Estimated Number of Participants
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Taiwan
180 participants
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Global
880 participants
