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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cancer, Liver Cancer, Hepatocellular Carcinoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

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

Outcome Measure:

Disease-Free Survival (DFS)

Outcome Description:

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

Outcome Time Frame:

End of study

Safety Issue:

No

Principal Investigator

Pei-Jer Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

United States: Food and Drug Administration

Study ID:

CT-PI-31

NCT ID:

NCT01402908

Start Date:

August 2011

Completion Date:

December 2015

Related Keywords:

  • Cancer
  • Liver Cancer
  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • PI-88
  • Phase III
  • Adjuvant Therapy
  • Hepatoma
  • Liver Cancer
  • Carcinoma
  • Hepatitis
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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