Clinical trial · Interventional
Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer
Neoadjuvant FOLFOXIRI (Irinotecan, Oxaliplatin and Fluorouracil) Chemotherapy in Patients With Locally Advanced Colon Cancer：an Open-label, Single-arm, Multicenter Phase II Study
NCT03484195CI-TRIAL-00051313unknownPhase 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)
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.
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 |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Drug Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOXIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOXIRI
- description
- Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection.
- interventionNames
- Drug: FOLFOXIRI
Primary outcomes (1)
- measure
- The ratio of tumor downstaging to stage 0 and stage I
- timeFrame
- 2 years
- description
- Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Secondary outcomes (7)
- measure
- Tumor regression grade (TRG)
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age: 18-75years old * Primary and pathological diagnosis of colon adenocarcinoma * Radiographic evaluation of initial resectable colon cancer * T4b colon cancer * ECOG status: 0～1 * Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×10\^9/L Platelet count≥90×10\^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 \* ULN Alanine aminotransferase (ALT)≤2.5 \* ULN Aspartate aminotransferase (AST)≤2.5 \* ULN Alkaline phosphatase (ALP)≤2.5 \* ULN * Signed informed consent; able to comply with study and/or follow- up procedures Exclusion Criteria: * Previous treatment with oxaliplatin, irinotecan or fluorouracil * Hypersensitivity to fluorouracil, oxaliplatin or irinotecan. * With distant metastasis * Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months * Digestive system diseases that would preclude study treatment or follow-up within the past 6 months * Gastric ulcers or duodenal ulcers for the treatment of resistance; * 3 or 4 grade gastrointestinal bleeding / bleeding; * Gastrointestinal perforation / fistula; * abdominal abscess; * Infectious or inflammatory bowel disease * HIV infection and/or active hepatitis B virus infection * Pregnant or lactating women. Fertile patients must use effective contraception * Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study * Other intervention clinical trials were combined at the same time. * Nerve or mental abnormality affecting cognitive ability * Other malignancy except effectively treated squamous cell or basal cell skin cancer, * Other situations that the researchers think should be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.