A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, International Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma (PATHWAY) - PATHWAY

PROGEN PHARMACEUTICALS LIMITED0 个研究点目标入组 600 人开始时间: 2009年8月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Histologically-proven hepatocellular carcinoma with curative resection performed within 4-6 weeks prior to randomisation and confirmed by negative follow-up chest and abdominal CT scans and abdominal MRI scan 2. Age ≥18 years 3. Written, signed and dated informed consent to participate in study 4. Able and willing to meet all protocol-required treatments, investigations and visits. This must include the ability for the subject to comply with daily self-administration of a subcutaneous injection, or reliable means for injections to be administered by a dependable third party such as a relative or caregiver. 5. ECOG performance status 0 to 2 6. Child Pugh classification A or B 7. ALT & AST within 2.5 times upper limit of normal (ULN) 8. Total bilirubin within 1.5 times upper limit of normal (ULN) 9. Platelet count ≥ 100 x 109 cells / litre 10. PT-INR less than 1.3 times upper limit of normal (ULN) 11. aPTT within normal range
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Any evidence of tumour metastasis or co-existing malignant disease 2. Any prior history of malignant disease, except:- (a) Non-invasive, non-melanomatous skin cancer (b) Treated in-situ cancer of the cervix 3. Any prior recurrence of HCC or any liver resection prior to the most recent procedure 4. Clinically significant non-malignant disease. Subjects who have experienced post-operative complications of liver resection may be enrolled providing that such complications are fully resolved at the time of screening. 5. Significant laboratory abnormalities including, but not limited to:- (a) Total white blood cell (WBC) count < 2.3 x 109 / litre (<2,300 /mm3) (b) Total neutrophil count < 1.5 x 109 / litre (1,500 /mm3) (c) Serum creatinine > 1.5 times upper limit of normal (ULN) 6. History of prior HCC therapy including, but not limited to, radiofrequency ablation, chemoembolization, chemotherapy, radiotherapy, molecular targeting agents, vaccines, liver transplantation or surgical resection prior to the most recent hepatectomy, at any time prior to screening 7. History of allergy and / or hypersensitivity and / or other clinically significant adverse drug reaction to heparin or other anti-coagulant agents See protocol for others

发起方