A study comparing the standard treatment of transarterial chemoembolisation (TACE)plus low doses of chemotherapy (cyclophosphamide) with an immune cell derived vaccine

Phase 1

• Conditions: Hepatocellular carcinoma; MedDRA version: 20.0Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001690-62-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-25
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1.Histological or cytological diagnosis or meet the AASLD criteria for
diagnosis of HCC and at least one uni-dimensional lesion measurable
according to the RECIST 1.1 criteria by CT-scan or MRI.
2.Suitable for TACE
3.Aged = 18 years and estimated life expectancy = 6 months
4.Not a candidate for surgical resection or transplantation
5.No previous chemotherapy, radiotherapy, immunotherapy or other experimental
treatment for HCC prior to entry into the trial
6.ECOG performance status = 2
7.Adequate haematological function: Hb = 90g/L, Absolute neutrophil count
= 1.5x109/L, platelet count = 50x10^9/L
8.Bilirubin = 50 µmol/L, AST or ALT = 5 x ULN
9.Adequate renal function: Cockroft and Gault estimation = 40ml/min
10.INR = 1.5
11.Child-Pugh score = 7
12.Women of child-bearing potential should have a negative pregnancy test prior
to trial entry
13.Women of child-bearing potential and men who have partners of child-bearing
potential must be willing to practise effective contraception for the
duration of the study and for three months after the completion of
treatment.
14.Written informed consent
15. Suitable veins for access with 17G fistula needle

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

1.Extra-hepatic metastasis
2.Prior embolisation, systemic or radiation therapy for HCC
3.Investigational therapy or major surgery within 4 weeks of trial entry
4.Any ablative therapy (RFA or PEI) for HCC (this should not exclude patients
if target lesion(s) have not been treated and occurred >6 weeks prior trial
entry)
5.Child Pugh score >7
6.Hepatic encephalopathy
7.Ascites refractory to diuretic therapy
8.Documented invasion of the main portal vein
9.Hypersensitivity to intravenous contrast agents
10.Active clinically serious infection > grade 2 CTCAE version 4 within
preceding 2 weeks
11.Pregnant or lactating women
12.History of second malignancy except those treated with curative intent more
than three years previously without relapse and non-melanotic skin cancer or
cervical carcinoma in situ
13.Evidence of severe or uncontrolled systemic diseases, congestive cardiac
failure > NYHA class 2, Myocardial Infection within 6 months or laboratory
finding that in the view of the investigator makes it undesirable for the
patient to participate in the trial
14.Psychiatric or other disorder likely to impact on informed consent
15.Known history of HIV
16.Patient is unable and/or unwilling to comply with treatment and trial
instructions
17.Patients with active auto-immune disorder
18. Hypersensitivity to cyclophosphamide or to any of its metabolites
19. Current cystitis infection
20. Urinary outflow obstruction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified