Spots Global Cancer Trial Database for A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection
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Trial Identification
Brief Title: A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection
Official Title: A Prospective, Randomized, Double-blind, Placebo Controlled, Parallel-group, International Multicenter Phase III Trial of PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection
Study ID: NCT01402908
Study Description
Brief Summary: The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.
Detailed Description: Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Peking Union Medical College Hospital, Beijing, , China
The General Hospital of People's Liberation Army (301 hospital), Beijing, , China
Fudan University Zhongshan Hospital, Shanghai, , China
Queen Mary Hospital, Hong Kong, , Hong Kong
Kyungpook National University Hospital (KNUH), Pusan, , Korea, Republic of
Pusan National University Hospital (PNUH), Pusan, , Korea, Republic of
Pusan National University Yangsan Hospital (PNUYH), Pusan, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Seoul St. Mary Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Changhua Christian Hospital, Changhua City, , Taiwan
E-Da Hospital, Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital-Linkou Medical Centre, Taoyuan, , Taiwan
Contact Details
Name: Pei-Jer Chen, MD
Affiliation: National Taiwan University Hospital
Role: PRINCIPAL_INVESTIGATOR
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