Clinical trial · Interventional
Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer
Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion(EMVI) Positive Rectal Cancer: A Phase II, Single-arm, Prospective Clinical Study
NCT04170530CI-TRIAL-00041786unknownPhase 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)
Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.
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 |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFOXIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mFOLFOXIRI
- description
- patients received FOLFOXIRI alone for 6 cycles before surgery.
- interventionNames
- Drug: mFOLFOXIRI
Primary outcomes (1)
- measure
- MFS
- timeFrame
- Three years
- description
- metastasis free survival
Secondary outcomes (7)
- measure
- Tumor downstaging rate
- timeFrame
- 2 years
- description
- the proportion of tumor downstaging to ypT0-2N0M0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 18 to 75 years at diagnosis; 2. ECOG status 0 or 1; 3. Signed informed consent; able to comply with study and/or follow- up procedures; 4. Diagnosis of rectal adenocarcinoma; 5. Distal border of the tumor must be located \< 12 cm from the anal verge; 6. MRI examination diagnosed EMVI-positive; 7. Tumor amenable to curative resection; 8. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Neutrophilic granulocytes ≥ 3.0 x10\^9/L, Platelet count ≥ 75 x 10\^9/L, Hemoglobin (Hb) ≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x ULN. 9. No renal disease that would preclude study treatment or follow-up Exclusion Criteria: 1. Hypersensitivity to fluorouracil, oxaliplatin or irinotecan; 2. Patient had received pelvic radiotherapy; 3. Patient had received systemic chemotherapy; 4. History of invasive colon or rectal malignancy, regardless of disease-free interval; 5. Had metastatic disease; 6. Patient had second malignant disease within 5 years; 7. Uncontrolled co-morbid illnesses or other concurrent disease; 8. Patients refused to signed informed consent. 9. Pregnant and Nursing women;
References
Publications (0)
Data not yet available
No reference posted for this study.