A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection

Phase 3

Terminated

Conditions: Cancer
Liver Cancer
Hepatocellular Carcinoma

Interventions: Other: Placebo
Drug: PI-88

Registration Number: NCT01402908

Lead Sponsor: Cellxpert Biotechnology Corp.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 520

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Arm 2
PI-88	PI-88	Arm 1

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS)	End of study	To evaluate the efficacy of daily administration of PI-88 versus placebo for the adjuvant treatment of study subjects as measured by DFS during study period. As the median DFS could not be estimated, the overall 25 th percentile DFS was reported.

Secondary Outcome Measures

Name	Time	Method
Time to Recurrence (TTR)	Time to recurrence (TTR) was defined as the time from randomization to the first time that tumor recurrence was observed or suspected during the study period (3 years).	As no subjects died without a preceding tumor recurrence , no median time to TTR could be estimated in the present study. And therefore the overall 25th percentile DFS was reported. The results of time to recurrence (TTR) were the same as that of DFS, as no subjects died without a preceding tumor recurrence.
Overall Survival (OS)	Overall survival was defined as the time, in weeks, from randomization to death from any cause during the study period (3 years).	Overall survival was defined as the time, in weeks, from randomization to death from any cause during the study period.
Tumor Recurrence Rate (TR Rate)	The cumulative tumor recurrence rate at weeks 5, 53, 101 and 149 was reported here.	TR rate was to calculate number of subjects with recurrence among the analyzed population.

Trial Locations

Locations (25): China Medical University Hospital
🇨🇳
Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳
Taipei City, Taiwan
Korea University Guro Hospital
🇰🇷
Seoul, Korea, Republic of
Seoul St. Mary Hospital
🇰🇷
Seoul, Korea, Republic of
Changhua Christian Hospital
🇨🇳
Changhua City, Taiwan
E-Da Hospital
🇨🇳
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital
🇨🇳
Kaohsiung, Taiwan
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
Kyungpook National University Hospital (KNUH)
🇰🇷
Pusan, Korea, Republic of
Pusan National University Hospital (PNUH)
🇰🇷
Pusan, Korea, Republic of
Ajou University Hospital
🇰🇷
Suwon, Korea, Republic of
Chang Gung Memorial Hospital-Linkou Medical Centre
🇨🇳
Taoyuan, Taiwan
National Cheng Kung University Hospital
🇨🇳
Tainan, Taiwan
Gangnam Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
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
Pusan National University Yangsan Hospital (PNUYH)
🇰🇷
Pusan, Korea, Republic of
Taichung Veterans General Hospital
🇨🇳
Taichung, Taiwan
Queen Mary Hospital
🇭🇰
Hong Kong, Hong Kong