Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Transgene
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with advanced disease without any other standard of care treatment options:
* hepatic metastases of colorectal cancer (CRC) or of other cancers
* Hepatocellular carcinoma (HCC)
At least one unresectable target tumor located in the liver, measuring 2-5 cm and accessible to IT administration of TG4023 and amenable to radiological measurement using RECIST,
Weight ≤ 100 kg,
Patients with stable disease, who have to discontinue chemotherapy because of intolerance,
ECOG performance status ≤ 2,
Life expectancy ≥ 3 months,
Hematology:
* Absolute neutrophil count \> 1,500/mm3,
* Hemoglobin \> 9g/dL,
* Platelet count \> 100,000/mm3,
* Prothrombin time international normalized ratio (INR) ≤ 2; partial thromboplastin time ≤ 1.66 times upper limit of normal (ULN),
Anti-vitamin K anticoagulants should have been switched for low-molecular weight heparin prior to TG4023 injection,
Signed, written Independent Ethics Committee (IEC)-approved informed consent.
You may not be if
Child-Pugh stage C hepatic insufficiency,
Impaired renal function (creatinin clearance \< 40 mL/min),
Known deficiency in dihydropyrimidine dehydrogenase (DPD) or total DPD deficiency diagnosed at baseline in those patients not previously treated with 5-FU-related compounds,
Ascites,
Brain metastases,
Significant impairment of gastro-intestinal (GI) tract absorption capacity, such as total gastrectomy, gastric mucosal atrophy, extensive intestinal resections or malabsorption disease will not be treated by oral 5-FC,
History of bleeding disorders,
Pregnant or breast-feeding women,
Human Immunodeficiency Virus (HIV) positive,
Chronic use of immunodepressants within 4 weeks prior to TG4023 injection or immune-depressed patients,
Hypersensitivity to 5-FC,
Hypersensitivity to egg proteins,
Concomitant or previous chemotherapy or targeted therapy within 4 weeks prior to TG4023 injection and last treatment with bevacizumab (Avastin®) within 2 months prior to TG4023 injection,
Concomitant treatment with anti-inflammatory drugs: systemic cortico-steroids and non-steroidal anti-inflammatory drugs (NSAIDs),
Prior gene therapy,
Prior participation in any other research protocol involving an IMP within 2 months prior to TG4023 injection,
