Clinical trial · Interventional
Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer
Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer:an Open-label, Single-arm, Multicenter Phase II Study
NCT03487939CI-TRIAL-00051338unknownPhase 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 resectable liver metastasis of colorectal 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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| 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
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria * Age: 18-75years old * Histologically confirmed colorectal cancer with liver metastasis (all patients should have the pathological report of colorectal cancer). The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. * It was confirmed by imaging that the liver metastases and the primary intestinal lesions were all resectable. * Radical resection of colorectal cancer after adjuvant chemotherapy complete 1 years later with liver metastases. * There is at least one measurable objective tumor of the tumor (according to the 1.1 version of RECIST standard). * Liver metastases can be excised by R0 and sufficient normal liver tissue can be retained * 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: * Hypersensitivity to fluorouracil, oxaliplatin or irinotecan. * In addition to liver metastases, there are other parts of 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 * 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.