Clinical trial · Observational
Observational Study on Second Line Treatment of Liver Metastases With DEBIRI and Cetuximab
Observational Study on Second Line Treatment of Colorectal Liver Metastases (KRas wt) by Hepatic Intra-arterial Chemoembolization With Dc Beads 70-150 μm Microspheres Preloaded With Irinotecan 200 Mgr Plus Systemic Cetuximab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new embolization materials. * An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in patients with liver metastases from colon cancer, who had been pretreated with 2 or more lines of chemotherapy. * Since a greater activity was attained by a combination of Cetuximab and Irinotecan versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal Products (EMEA) has granted authorization to the use of Cetuximab in association with irinotecan in the treatment of irinotecan-refractory CRC-LM. * In this study we want to collect data on on time to progression and tolerability using DEBIRI+Cetuximab in LM-CRC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Liver Metastasis | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Tacetux
- description
- DEBIRI+ CETUXIMAB ADMINISTRATION
- label
- DEBIRI
- description
- only DEBIRI treatment
Primary outcomes (1)
- measure
- time to progression
- timeFrame
- one year
Secondary outcomes (1)
- measure
- number of adverse events
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Unresectable hepatic metastases from colorectal carcinoma (CRC-LM) 2. Progression of disease after first line therapy containing Irinotecan completed at least one month previously 3. Performance status (PS) 0-2 4. Biochemistry parameters within normal limits (ALT and gamma glutamyl transpeptidase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/ml) 5. Adequate information and subsequent written informed consent 6. Life expectancy \> 3 months 7. Patients K-RAS wild type Exclusion Criteria: 1. Extension of disease greater than 50% of the parenchymal liver (confirmed by CAT scan or MRI) 2. Brain metastases 3. Severe and confirmed vascular diseases 4. Other concomitant malignancies except for cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix 5. Evidence of significant diseases such as uncontrolled diabetes, congestive heart failure, chronic renal insufficiency (CRI) 6. Known hypersensitivity reactions towards components of the study drugs 7. Pregnant or breastfeeding women or women of childbearing potential not making use of effective contraceptives 8. Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up and from complying with protocol procedures 9. Patients K-RAS mutant
References
Publications (2)
- RESULTFiorentini G, Aliberti C, Tilli M, Mulazzani L, Graziano F, Giordani P, Mambrini A, Montagnani F, Alessandroni P, Catalano V, Coschiera P. Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res. 2012 Apr;32(4):1387-95. PMID 22493375
- DERIVEDGuadagni S, Fiorentini G, Clementi M, Palumbo P, Mambrini A, Masedu F. Mitomycin C hypoxic pelvic perfusion for unresectable recurrent rectal cancer: pharmacokinetic comparison of surgical and percutaneous techniques. Updates Surg. 2017 Sep;69(3):403-410. doi: 10.1007/s13304-017-0480-6. Epub 2017 Aug 8. PMID 28791628