Clinical trial · Interventional
PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES
NCT02086656CI-TRIAL-00039916COI-BcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline and/or high risk resectable colorectal cancer liver metastases
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 |
|---|---|---|---|
| Colorectal Cancer Liver Metastases | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine, oxaliplatin, irinotecan and bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- open label
- description
- Single arm, open label
- interventionNames
- Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab
Primary outcomes (1)
- measure
- Pathological response rate
- timeFrame
- Assessed at the time of surgery of liver metastases (between weeks 17-20 from enrollment)
- description
- Primary: \- To evaluate the activity of the regimen with regards to major/complete pathological response. Major/complete pathological response is measured by pathologist in terms of tumor regression grade (TRG) as described by Rubbia-Brandt L, Annals of Oncology 2007 (percentage of vial residual cells 0-10%).
Secondary outcomes (1)
- measure
- RECIST Response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria: * Histological diagnosis of colorectal adenocarcinoma. * Liver-limited metastases or metastases mainly (≥80% total disease burden) limited to the liver with extrahepatic disease judged resectable concomitantly or sequentially. Primary tumor may be resected or not, but patient must not be symptomatic for T. * Previous adjuvant therapy is allowed if it had been terminated for at least 6 months. * Previous first line treatment (irinotecan or oxaliplatin containing regimen) with stable or partial response after no more than 3 months of treatment * Age \>= 18 years * Performance Status (ECOG \<2) * Adequate organ function including the following: * Adequate bone marrow reserve: WBC count \>3.0x109/L, absolute neutrophil count \>1.5x109/L, platelet count \>100x109/L, and hemoglobin \>10 g/dL . * Hepatic: bilirubin \< 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \< 2.5 xULN * Renal : serum creatinin \<2.0xULN * Patients compliance and geographic proximity that allows for adequate follow-up * Patients must sign an informed consent document (ICD) * Male and female patients with reproductive potential must use an approved contraceptive method. Exclusion Criteria: * Tumor involvement of liver \> 75% * Chance of a liver remnant after surgery \< 25% * Eligibility for concurrent radiotherapeutic treatment * Disease progression during first line chemotherapy with FOLFOX, XELOX, FOLFIRI or XELIRI plus bevacizumab * Previous treatment with more than 3 months of FOLFOX or FOLFIRI * Previous therapy with bevacizumab or cetuximab or panitumumab * Administration of other experimental drugs during the study. * Body Mass Index \> 35 * Brain metastases. * Pregnancy and breast-feeding. * Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment. Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis. * Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures. Peripheral neuropathy not related to oxaliplatin previous administration. * Previous dangerous life threatening toxicities from fluoropyrimidine. * Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.
References
Publications (0)
Data not yet available
No reference posted for this study.