Clinical trial · Interventional
Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
- 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)
An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Therefore, the investigators propose a prospective study of neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver metastasis to potentially resectable disease.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Unresectable Liver Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX6/cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NEO
- description
- NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab
- interventionNames
- Drug: FOLFOX6/cetuximab
Primary outcomes (1)
- measure
- To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis
- timeFrame
- 18 months
Secondary outcomes (4)
- measure
- Response rate (according to RECIST)
- timeFrame
- 24 months
- measure
- Progression-free survival time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven colorectal cancer with metastatic lesion(s) in the liver that is (are) unresectable * Age ≥ 18 * ECOG performance 0 - 1 * Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin \< 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet \> 100,000/ul, absolute neutrophil count ≥ 1,500/ul) * At least one measurable lesion by RECIST criteria * Written informed consent Exclusion Criteria: * Resectable liver metastasis * Extrahepatic metastases, regardless of their resectability * Chronic active hepatitis or cirrhosis * Prior therapy for metastatic disease * Pregnant or lactating women * Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months * Previous adjuvant FOLFOX chemotherapy * Prior adjuvant chemotherapy, if administered within 6 months before study entry * Known hypersensitivity reaction to any of the components of study treatment * Prior agents directed against EGFR * Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy * Known alcohol or drug abuse * Participation in another clinical study within the 30 days before registration * Peripheral neuropathy \> grade 1 * Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin of pre-invasive carcinoma of the cervix.
References
Publications (0)
Data not yet available