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A Phase III Study of PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related Hepatocellular Carcinoma After Surgical Resection (PATRON)

This study is currently recruiting participants.
Verified June 2012 by Medigen Biotechnology Corporation
Sponsor:
Information provided by (Responsible Party):
Medigen Biotechnology Corporation
ClinicalTrials.gov Identifier:
NCT01402908
First received: July 25, 2011
Last updated: April 1, 2013
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
Liver Cancer
Hepatocellular Carcinoma
 Drug: PI-88
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Hepatocellular Carcinoma After Surgical Resection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medigen Biotechnology Corporation:

Primary Outcome Measures:
  • Disease-Free Survival (DFS) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Time to Recurrence (TTR) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    The secondary objectives are to evaluate (a) safety and (b) efficacy, as measured by time to recurrence (TTR), overall survival (OS), tumor recurrence (TR) rate.

  • Overall Survival (OS) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    The secondary objectives are to evaluate (a) safety and (b) efficacy, as measured by time to recurrence (TTR), overall survival (OS), tumor recurrence (TR) rate.

  • Tumor Recurrence (TR) rate [ Time Frame: End of study ] [ Designated as safety issue: No ]
    The secondary objectives are to evaluate (a) safety and (b) efficacy, as measured by time to recurrence (TTR), overall survival (OS), tumor recurrence (TR) rate.


Estimated Enrollment: 500
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PI-88
Arm 1
 Drug: PI-88
Lyophilized powder reconstituted to provide 160 mg of PI-88
Placebo Comparator: Placebo
Arm 2
 Other: Placebo
Lactose lyophilized powder

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

The key inclusion criteria are listed below:

  • Histological diagnosis of primary HCC
  • Curative resection within 4-6 weeks prior to randomisation (proven by clear resection margin (> 0.1 cm) + negative chest and tri-phasic contrast enhanced spiral CT scan + negative abdominal contrast enhanced MRI). Patients with residual lymph node metastases should not be enrolled.
  • Known positive serum HBsAg or known HCV in serum
  • ECOG PS 0-1
  • Child Pugh score < 8

The key exclusion criteria are listed below:

  • Pathological confirmation of single tumour <2cm in diameter from most recent hepatectomy
  • History of immune-mediated thrombocytopenia, other platelet disorders, laboratory evidence of anti-heparin antibodies, or prior history thereof
  • Metastatic tumour or co-existing malignant disease
  • Prior history of malignancy except non-melanomatous skin cancer or treated in-situ carcinoma of the cervix
  • Prior recurrence of HCC or any liver resection prior to the most recent resection
  • Prior HCC therapy including chemotherapy, radiotherapy, molecular targeted agents, vaccines, liver transplantation or surgical resection prior to most recent hepatectomy. Pre-operative portal vein embolisation is permitted
  • Planned liver transplantation
  • History of allergic and/or hypersensitivity and/or significant adverse reactions to heparin or other anticoagulants
  • Concomitant aspirin (>150mg/day), vitamin K antagonists (other than low dose prophylaxis), NSAIDs (except COX-2 inhibitors), heparin within 2 weeks prior to randomisation or other anti-platelet drugs.
  • History of allergic, anaphylactic or significant adverse reaction to radiographic contrast media which cannot be managed by pre-treatment prophylaxis or patient unsuitable for CT or MRI scanning.
  • Known seropositivity to HIV
  • Inflammatory bowel disease , abnormal bleeding tendency or at risk of bleeding due to open wounds or planned surgery
  • Acute substance abuse including alcohol
  • Anticancer therapy or investigational agent in the previous 4 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402908

Contacts
Contact: Stanley Chang, MD, PhD +886-2-2653-5200 ext 880 sscchang@medigen.com.tw
Contact: Conrad Lai, PhD +886-2-2653-5200 ext 600 conrad@medigen.com.tw

Locations
China, Hunan
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
Contact: Feizhou Huang, MD     +86 150 07318341     huangfeizhou@hotmail.com    
Contact: Yuping Zhang, MD         thirdmed@163.com    
Principal Investigator: Feizhou Huang, MD            
Sub-Investigator: Yuping Zhang, MD            
Sub-Investigator: Wanpin Nie, MD            
China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Yilei Mao, MD     +86 10 69156042     yileimao@126.com    
Contact: Xin Lu, MD            
Principal Investigator: Yilei Mao, MD            
Sub-Investigator: Xin Lu, MD            
Sub-Investigator: Yiyao Xu, MD            
The General Hospital of People's Liberation Army (301 hospital) Recruiting
Beijing, China
Contact: Jiahong Dong, MD     +86 10 6693 8030     dongjh301@163.com    
Contact: Yongwei Chen     +86 10 6693 8334     chenyw301301@sina.com    
Principal Investigator: Jiahong Dong, MD            
Sub-Investigator: Yongwei Chen, MD            
Sub-Investigator: Chen Lin, MD            
Fudan University Zhongshan Hospital Recruiting
Shanghai, China
Contact: Jia Fan     +86 21 64439027     fan.jia@zs-hospital.sh.cn    
Contact: Huichuan Sun     +86 21 6441990 ext 3239     sun.huichuan@zs-hospital.sh.cn    
Principal Investigator: Jia Fan, MD            
Sub-Investigator: Huichuan Sun, MD            
Sub-Investigator: Dong Wu, Radiologist            
Sub-Investigator: Jian Zhou, MD            
Sub-Investigator: Shuangjian Qiu, MD            
Sub-Investigator: Qinghai Ye, MD            
Sub-Investigator: Lu Wang, MD            
Sub-Investigator: Xiaoying Wang, MD            
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Tungping Poon, MD     +852 2255 3641     poontp@hku.hk    
Contact: Tanto Cheung, MD     +852 2255 3025     tantocheung@hotmail.com    
Principal Investigator: Tungping Poon, MD            
Sub-Investigator: Tanto Cheung, MD            
Sub-Investigator: Wingchiu Dai, MD            
Sub-Investigator: Chungcheung Yau, MD            
Sub-Investigator: Chingyu Leung, MD            
Korea, Republic of
Kyungpook National University Hospital (KNUH) Recruiting
Pusan, Korea, Republic of
Contact: Young Oh Kweon, MD     +82-53-420-5518     yokweon@gmail.com    
Contact: Soo Young Park, MD         psyoung0419@gmail.com    
Principal Investigator: Young Oh Kweon, MD            
Sub-Investigator: Soo Young Park, MD            
Pusan National University Yangsan Hospital (PNUYH) Recruiting
Pusan, Korea, Republic of
Contact: Mong Cho     +82-55-360-2350     mcho@pusan.ac.kr    
Contact: KiTae Yoon         kiyoon@pusan.ac.kr    
Principal Investigator: Mong Cho, MD            
Sub-Investigator: KiTae Yoon, MD            
Pusan National University Hospital (PNUH) Recruiting
Pusan, Korea, Republic of
Contact: Jeong Heo, MD     +82-51-240-7869     sodium@korea.com    
Contact: HyunYoung Woo, MD         who54@hanmail.net    
Principal Investigator: Jeong Heo, MD            
Sub-Investigator: HyunYoung Woo, MD            
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Han-Chu Lee     +82-2-3010-3915     hch@amc.seoul.kr    
Contact: Su Mi Park     +82-2-3010-7349     sumipark@amc.seoul.kr    
Principal Investigator: Han Chu Lee, MD            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jung-Hwan Yoon, MD     +82-2-2072-2731     ydoctor2@hanmail.net    
Contact: Su-Jong Yu, MD     +82-10-6288-0422     ydoctor2@hanmail.net    
Principal Investigator: Jung Hwan Yoon, MD            
Sub-Investigator: Su Jong Yu, MD            
Seoul St. Mary Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jong-Young Choi     +82-2-2258-7565     jychoi@catholic.ac.kr    
Contact: Hee Yeon Kim     +82-2-2258-2073     hee82@catholic.ac.kr    
Principal Investigator: Jong Young Choi, MD            
Sub-Investigator: Hee Yeon Kim, MD            
Sub-Investigator: Seung Kew Yoon, MD            
Sub-Investigator: Si-Hyun Bae, MD            
Sub-Investigator: Myeong Jun Song, MD            
Sub-Investigator: Do Seon Song, MD            
Sub-Investigator: Sun Hong Yoo, MD            
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kwan Sik Lee, MD     +82-2-2019-3314     leeks519@yuhs.ac    
Contact: Ja kyung Kim, MD     +82-2-2019-3302     ceciliak@yuhs.ac    
Principal Investigator: Kwan Sik Lee, MD            
Sub-Investigator: Ja Kyung Kim, MD            
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: Kwang-Hyub Han, MD     +82-2-2228-1949     gihankhys@yuhs.ac    
Contact: Sang Hoon Ahn, MD     +82-10-5419-8087     ahnsh@yuhs.ac    
Principal Investigator: Kwang-Hyub Han, MD            
Sub-Investigator: Sang Hoon Ahn, MD            
Sub-Investigator: Jin Sub Choi, MD            
Sub-Investigator: Gi Hong Choi, MD            
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung Woon Paik, MD     +82-2-3410-3402     swpaik@skku.edu    
Contact: Joon Hyoek Lee, MD     +82-2-3410-3409     gijhlee.lee@samsung.com    
Principal Investigator: Seung Woon Paik, MD            
Sub-Investigator: Joon Hyoek Lee, MD            
Sub-Investigator: Yong Han Paik, MD            
Sub-Investigator: Geum-Youn Gwak, MD            
Sub-Investigator: Yang Won Min, MD            
Sub-Investigator: Joh Jae Won, MD            
Sub-Investigator: Choon Hyuck Kwon, MD            
Sub-Investigator: Jong Man Kim, MD            
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kwan Soo Byun     +82-2-2626-3009     kwsbyun@unitel.co.kr    
Contact: Hyun Jung Lee     +82-10-9074-1872     mothpickle@naver.com    
Principal Investigator: Kwan Soo Byun, MD            
Sub-Investigator: Hyun Jung Lee, MD            
Sub-Investigator: Sang Joon Seo, MD            
Sub-Investigator: Jong Eun Yeon, MD            
Sub-Investigator: Eileen Laurel Yoon, MD            
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Hee Jung Wang, MD     +82-31-219-5204     wanghj@ajou.ac.kr    
Contact: Da Hye Kang     +82-31-219-5547     rkdek1@hanmail.net    
Principal Investigator: Hee Jung Wang, MD            
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Kaohsiung City, Taiwan
Contact: Pei-Jer Chen, MD, PhD     +886-2-2312-3456 ext 67072     peijerchen@ntu.edu.tw    
Contact: Po-Huang Lee, MD, PhD     +886-2-2312-3456 ext 65104     pohuang1115@ntu.edu.tw    
Principal Investigator: Pei-Jer Chen, MD, PhD            
Principal Investigator: Po-Huang Lee, MD, PhD            
Principal Investigator: Rey-Heng Hu, MD            
Sub-Investigator: Ming-Chih Ho, MD            
Sub-Investigator: Chun-Jen Liu, MD            
Sub-Investigator: Yao-Ming Wu, MD            
Sub-Investigator: Po-Chin Liang, MD            
Sub-Investigator: Kao-Lang Liu, MD            
Changhua Christian Hospital Recruiting
Changhua City, Taiwan
Contact: Wei-Wen Su, MD     +886-4-7238595 ext 5505     35301@cch.org.tw    
Contact: Yao-Li Chen, MD     +886-4 7238595 ext 1013     31560@cch.org.tw    
Principal Investigator: Wei-Wen Su, MD            
Sub-Investigator: Yao-Li Chen, MD            
Sub-Investigator: Shun-Sheng Wu, MD            
Sub-Investigator: Yu-Chun Hsu, MD            
Sub-Investigator: Hsu-Heng Yen, MD            
Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Chao-Long Chen     +886-7-7317123 ext 8097     clchen@adm.cgmh.org.tw    
Contact: Chih-Chi Wang, MD     +886- 7-7317123 ext 8093     ufel4996@ms26.hinet.net    
Principal Investigator: Chao-Long Chen, MD            
Sub-Investigator: Chih-Chi Wang, MD            
Sub-Investigator: Chih-Che Lin, MD            
E-Da Hospital Recruiting
Kaohsiung City, Taiwan
Contact: Yaw-Sen Chen, MD     +886- 7-6150011 ext 251296     yawsen.chen@msa.hinet.net    
Contact: Chih-Wen Lin, MD     +886- 7-6150011 ext 251179        
Principal Investigator: Yaw-Sen Chen, MD            
Sub-Investigator: Chih-Wen Lin, MD            
Sub-Investigator: Pei-Min Hsieh, MD            
Sub-Investigator: Chuan-Yuan Hsu, MD            
Sub-Investigator: Po-Lin Sun, MD            
Chang Gung Memorial Hospital-Linkou Medical Centre Recruiting
Kwei-Shan, Taiwan
Contact: Wei-Chen Lee, MD     +886-3-3281200 ext 3366     weichen@adm.cgmh.org.tw    
Contact: Deng-Yn Lin, MD     +886-3-3281200 ext 8108     lindy0043@adm.cgmh.org.tw    
Principal Investigator: Wei-Chen Lee, MD            
Sub-Investigator: Deng-Yn Lin, MD            
Sub-Investigator: Ming-Chin Yu, MD            
Sub-Investigator: Kun-Ming Chan, MD            
Sub-Investigator: Hong-Shiue Chou, MD            
Sub-Investigator: Chen-Fang Lee, MD            
Sub-Investigator: Chien-Fu Hung, MD            
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Long-Bin Jeng, MD     +886-4-22052121 ext 1765/1764     surgery@www.cmuh.org.tw    
Contact: Mei-Due Yang, MD     +886-4-22052121 ext 4129     d5218@mail.cmuh.org.tw    
Principal Investigator: Long-Bin Jeng, MD            
Sub-Investigator: Mei-Due Yang, MD            
Sub-Investigator: Horng-Ren Yang, MD            
Sub-Investigator: Cheng-Yuan Peng, MD            
Sub-Investigator: Po-Heng Chuang, MD            
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Contact: Cheng-Chung Wu, MD     +886-4-23592525 ext 5020     he@vghtc.gov.tw    
Contact: Hong-Zen Yeh, MD     +886-4-23592525 ext 3309     yhz@vghtc.gov.tw    
Principal Investigator: Cheng-Chung Wu, MD            
Sub-Investigator: Hong-Zen Yeh, MD            
Sub-Investigator: Sheng-Shun Yang, MD            
Sub-Investigator: Teng-Yu Lee, MD            
Sub-Investigator: Jen-I Hwang, MD            
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Pin-Wen Lin, MD     +886-6-2353535 ext 2010     pinwen@mail.ncku.edu.tw    
Contact: Yih-Jyh Lin, MD     +886-6-2353535 ext 5181     lyj007@mail.ncku.edu.tw    
Principal Investigator: Pin-Wen Lin, MD            
Sub-Investigator: Yih-Jyh Lin, MD            
Sub-Investigator: Yan-Shen Shan, MD            
Sub-Investigator: Tsung-Ching Chou, MD            
Sub-Investigator: Hong-Ming Tsai, MD            
Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan
Contact: Gar-Yang Chau, MD     +886-2- 28757535 ext 132     gychau@vghtpe.gov.tw    
Contact: Cheng-Yuan Hsia, MD     +886-2-28757535 ext 138     cyhsia@vghtpe.gov.tw    
Principal Investigator: Gar-Yang Chau, MD            
Sub-Investigator: Cheng-Yuan Hsia, MD            
Sub-Investigator: Yi-You Chiou, MD            
Sponsors and Collaborators
Medigen Biotechnology Corporation
Investigators
Principal Investigator: Pei-Jer Chen, MD National Taiwan University Hospital
  More Information

Additional Information:
Medigen Biotechnology Corporation Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medigen Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT01402908     History of Changes
Other Study ID Numbers: CT-PI-31
Study First Received: July 25, 2011
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration
Taiwan: Food and Drug Administration, Department of Health, Executive Yuan
South Korea: KFDA
China: SFDA
Hong Kong: DOH

Keywords provided by Medigen Biotechnology Corporation:
Hepatocellular Carcinoma
PI-88
Phase III
 Adjuvant Therapy
Hepatoma
Liver Cancer

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
 Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Adenocarcinoma
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013