Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Universitaire Ziekenhuizen KU Leuven
With
Biocompatibles UK Ltd
20 patients will be included. The duration of the trial will be approximately 24 months.
Every 8 weeks there will be a tumour lesion assessment.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
2. Primary tumour has been treated with complete surgical resection without evidence of residual tumour
3. Patients must have at least 1 measurable lesion (RECIST criteria)
* Serum creatinine £ 1.5 x upper limit of normal (ULN)
* Serum transaminases (AST \& ALT) £ 5 x ULN
* Bilirubin\> 1.5 times the upper limit of the normal range
10. Women of child bearing potential and fertile men are required to use effective contraception (negative βHCG for women of child-bearing age)
11. Signed, written informed consent
12. Patients with patent main portal vein
13. Maximum liver involvement ≤60%
You may not be if
1. Presence of CNS metastases
2. Contraindications to FU/LV, Irinotecan or Cetuximab
3. Active bacterial, viral or fungal infection within 72 hours of study entry
4. Women who are pregnant or breast feeding
5. Allergy to contrast media or history of severe hypersensitivity to study drugs.
6. Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
7. Any contraindication for hepatic embolization procedures:
* porto-systemic shunt
* hepatofugal blood flow
* severe atheromatosis
8. Contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
9. Other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
Clareo Health | Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC
