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Clinical Trials List

Protocol NumberCT-PI-31F

2017-12-01 - 2018-12-20

Others

Terminated8

Study ended1

ICD-10C22

Malignant neoplasm of liver and intrahepatic bile ducts

A Retrospective Chart Review Study of Patients Who Previously Participated in the PATRON Phase III Trial

Trial Applicant
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator REY-HENG HU Division of General Surgery

National Taiwan University Hospital

Co-Principal Investigator

Ming-Chih Ho Division of General Surgery
Chun-Jen Liu Division of General Internal Medicine
李伯皇 Division of General Surgery
KAI-WEN HUANG Division of General Surgery
PEI-JER CHEN Division of General Internal Medicine
Yao-Ming Wu Division of General Surgery

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wei-Chen Lee Division of General Surgery

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

吳庭榕 Division of General Surgery
Kun-Ming Chan Division of General Surgery
周宏學 Division of General Surgery
Ming-Chin Yu Division of General Surgery
周宏學 Division of General Surgery

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Gar-Yang Chau Division of General Surgery

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 鄭紹彬 Division of General Surgery

Taichung Veterans General Hospital

Co-Principal Investigator

葉宏仁 Digestive System Department
Sheng-Shun Yang Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 蘇維文 Digestive System Department

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

吳順生 Digestive System Department
陳堯俐 Division of General Surgery
蘇培元 Digestive System Department
顏旭亨 Digestive System Department
徐友春 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yih-Jyh Lin Division of General Surgery

National Taiwan University Hospital

Co-Principal Investigator

Yan-Shen Shan Division of General Surgery

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳肇隆 Division of General Surgery

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

林志哲 Division of General Surgery

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳耀森 Division of General Surgery

E-DA Hospital

Co-Principal Investigator

謝沛民 Division of General Surgery
林志文 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Long-Bin Jeng 未分科

China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Long-Bin Jeng Division of Others -

China Medical University Hospital

Co-Principal Investigator

楊宏仁 Division of General Surgery

The Actual Total Number of Participants Enrolled

7 Study ended

Condition/Disease

Adjuvant treatment of Post- Resection Hepatocellular Carcinoma

Objectives

The primary objective of this retrospective study is to extend the follow-up time for collecting more event information to compare disease-free survival (DFS) between the PI-88 and Placebo arms in the subgroups of vascular invasion status who were enrolled in the PATRON clinical trial. The secondary objectives are to further compare ‘overall survival (OS)’, ‘time to recurrence (TTR)’, and ‘tumor recurrence (TR) rate’ in these patients, as well as to summarize the HCC-related and antiviral hepatitis related treatments following the participation of PATRON study

Test Drug

Muparfostat (PI-88)

Active Ingredient

Dosage Form

Dosage

215

Endpoints

To extend the follow-up time to compare ‘overall survival (OS)’, ‘time to recurrence (TTR)’, and ‘tumor recurrence (TR) rate’ between the PI-88 and Placebo arms in the subgroups of vascular invasion status who were enrolled in the PATRON study

Inclution Criteria

Inclusion Criteria
· Subjects in the subgroups of “microvascular invasion” or “no vascular invasion” who were enrolled in the PATRON clinical trial.

Exclusion Criteria

Exclusion Criteria
· Subjects who had met the PATRON defined mortality prior to the early conclusion of the PATRON clinical trial.
· Subject’s medical chart data are missing or sabotaged.
· Refusal or inability of subject or subject’s legal representative, if the subject expired, to provide written consent to participate in the study, unless the documentation of informed consent is to be waived per the local ethic committee or regulatory authority’s approval.

The Estimated Number of Participants

Taiwan

143 participants
Global

256 participants