PI-88 in Hepatocellular Carcinoma After Hepatectomy

Phase 2

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: PI-88

• Registration Number: NCT00247728
• Lead Sponsor: Cellxpert Biotechnology Corp.

Brief Summary

The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.

Detailed Description

Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy.

In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-02
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2011-07-27
• Results First Submitted QC: 2020-10-19
• Results First Posted: 2020-11-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Patients have voluntarily given written informed consent

• Age ≥ 18 years but ≤ 75 years

• Males or females

• Histological diagnosis of hepatocellular carcinoma

• Curative hepatectomy within the past 4-6 weeks

• ECOG performance status of 0 to 2

• Cardiac functional capacity ≤ to class II (New York Heart Association)

• Patients with adequate renal, hepatic, and haematopoietic function as defined by:

  • Serum creatinine ≤ 2.0 mg/dL
  • Total bilirubin < 2.5 mg/dL
  • Neutrophil count > 1.5 x 10^9/L
  • ALT < 5 x upper limit of normal (ULN)
  • White blood cell (WBC) count ≥ 3 x 10^9/L
  • Platelet count ≥ 80 x 10^9/L
  • Prothrombin time international normalized ratio (PT-INR) ≤ 1.3 (or PT-INR ≤ 1.4 but PT within normal range)
  • Activated partial thromboplastin time (APTT) < ULN

Exclusion Criteria

• Patients with history of allergy and/or hypersensitivity to anticoagulants/thrombolytic agents, especially heparin.
• Patients with history of immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or other platelet disease
• Patients with previous positive result in a heparin-induced thrombocytopenia (HIT) antibody test.
• Patients with any tumour metastasis.
• Patients with uncontrolled infection or serious infection within the past 4 weeks.
• Patients with myocardial infarction, stroke, or congestive heart failure within the past 3 months.
• Patients with history of inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
• Patients with acute or chronic gastrointestinal bleeding within the past 1 year.
• Patients with a history of drug abuse or psychiatric disorder.
• Patients with known HIV infection or AIDS-related illness.
• Patients who received other investigational or anti-neoplastic medication within the past 4 weeks.
• Use of aspirin, aspirin-containing medications, non-steroidal anti-inflammatory drugs (except for COX-2 inhibitors), heparin, low molecular weight heparin, warfarin, anti-platelet drugs, or any other anticoagulant medications 2 weeks prior to or during the study period.
• Women who are pregnant or breast-feeding.
• Women of child-bearing potential who are not using an adequate method of contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
160 mg PI-88/Day	PI-88	PI-88 160 mg/day SC injection
250 mg PI-88/Day	PI-88	PI-88 250 mg/day SC injection

Primary Outcome Measures

Name	Time	Method
Tumour Non-recurrence Rate	Week 48	The tumor non-recurrence rate at the end of the 48-week study period

Secondary Outcome Measures

Name	Time	Method
Time to Recurrence	until confirmed tumour recurrence, or for a maximum of 48 weeks	Time to recurrence during the 48-week study period
Survival Rate	Week 48	Survival rate at the end of the 48-week study period

Trial Locations

Locations (6)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Chang Gung Memorial Hospital-Linkou Medical Centre; 🇨🇳 Taoyuan, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan