A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection (PATRON)
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
Sponsor: Cellxpert Biotechnology Corp.
Terminated
Due to Interim Analysis and business concerns
This PHASE3 trial investigates Cancer and Hepatocellular Carcinoma and is currently terminated or withdrawn. Cellxpert Biotechnology Corp. leads this study, which shows 9 recorded versions since 2011 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
9 versions recorded-
Dec 2025 — Present [monthly]
Terminated PHASE3
-
Sep 2025 — Dec 2025 [monthly]
Terminated PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Jul 2022 — Jul 2024 [monthly]
Terminated PHASE3
▶ Show 4 earlier versions
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Jan 2021 — Jul 2022 [monthly]
Terminated PHASE3
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Jun 2018 — Jan 2021 [monthly]
Terminated PHASE3
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Feb 2017 — Jun 2018 [monthly]
Terminated PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Terminated PHASE3
First recorded
Aug 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Cellxpert Biotechnology Corp.
- Medigen Biotechnology Corporation
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Beijing, China , Changhua, Taiwan , Changsha, China , Hong Kong, Hong Kong , Kaohsiung City, Taiwan , Pusan, South Korea , Seoul, South Korea , Shanghai, China , Suwon, South Korea , Taichung, Taiwan and 3 more locations