Sandostatin LAR in HCC

Phase 2

Active, not recruiting

• Conditions: Advanced Hepatocellular Carcinoma; Cancer - Liver

• Registration Number: ACTRN12605000699662
• Lead Sponsor: Site - Investigator Initiated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(All of the following): 4.1.1histological OR cytological evidence of hepatocellular carcinoma OR liver imaging suggestive of the diagnosis AND a plasma alpha-fetoprotein over 500 IU/mL. 4.1.2 Hepatocellular carcinoma which is unresectable. 4.1.3patient performance status (WHO) grade 0, 1 or 2.4.1.7women must have a negative pregnancy test prior to treatment; both men and women should have adequate contraception during the course of treatment.4.1.8written informed consent.

Exclusion Criteria

(None of the following: )4.2.1Previous octreotide treatment for hepatocellular carcinoma4.2.2patient performance status > (WHO) 3 4.2.3peripheral blood white cell count < 2.0 x 109/L, platelet count <50 x 109/L and haemoglobin < 10.0 g/L.4.2.4serum creatinine greater than or equal to 0.15mmol/L; serum bilirubin > 50 micromol/litre; serum albumin < 25 g/L; AST and ALT > 5x institutional upper limit of normal. Patients with Primary Biliary Cirrhosis (PBC) should be classified using Bilirubin levels defined for this patient group in the Childs-Pugh Score (see appendix 7).4.2.5prothrombin ratio (INR) > 2.04.2.6any inter-current illness that may significantly interfere with safe administration of Sandostatin LAR® or end-point evaluation; including refractory severe encephalopathy, symptomatic gallstone disease (either cholecystolithiasis or choledocholithiasis).4.2.7Treatment with somatostatin for other reasons4.2.8Concurrent anti-tumour treatment for HCC4.2.9pregnant women4.2.10previous malignancy within the last 5 years other than curatively resected non-melanoma skin cancer or carcinoma of the uterine cervix.4.2.11known reaction to the study drug4.2.12HIV positive patients4.2.13uncontrolled ascites requiring paracentesis within 4 weeks4.2.14variceal bleeding in the last month4.2.15prior radiation therapy to the only evaluable site of disease4.2.16refusal to give informed consent to participate in the study4.2.17Child-Pugh class C cirrhosis, (for patients with PBC use the adjusted bilirubin levels to classify the patient).4.2.18patients who are rendered artificially eligible by the administration of blood product support.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance with assessments[Montly assessments];Compliance with treatment[Montly assessments]

Secondary Outcome Measures

Name	Time	Method
Adverse events, including complications of cirrhosis[Monthly assessments];Accrual rate[Monthly assessments];Biopsy rate[Monthly assessments];Somatostatin receptor positivity rate[Monthly assessments];Subjective patient benefit[Monthly assessments];Quality of life[Monthly assessments];Tumour response[Monthly assessments];Time to progression[Monthly assessments];Overall survival[Monthly assessments];Somatostatin receptor status impact on survival[Monthly assessments];Pharmacokinetics of Sandostatin LAR ®[Monthly assessments];Effects of Sandostatin LAR ® on complications of cirrhosis[Monthly assessments];Comparison of methods for quantifying somatostatin receptors.[Monthly assessments]