Clinical trial · Interventional
A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC
A Multicenter Randomized Controlled Phase II Trial of Neoadjuvant mFOLFOXIRI Versus Routine Chemoradiotherapy in the EMVI Positive Locally Advanced Rectal Cancer (TRICHEMO)
NCT04423965CI-TRIAL-00050821unknownPhase 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 FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy | Combination Product | — | UNRESOLVED |
| mFOLFOXIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mFOLFOXIRI
- description
- Patients receive 6 cycles of mFOLFOXIRI
- interventionNames
- Drug: mFOLFOXIRI
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy(CRT)
- description
- Patients receive standard chemoradiotherapy
- interventionNames
- Combination Product: Chemoradiotherapy
Primary outcomes (1)
- measure
- MFS
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 18 to 70 years at diagnosis; 2. ECOG status 0-2; 3. Diagnosis of rectal adenocarcinoma(Distal border of the tumor must be located \< 12 cm from the anal verge); 4. MRI examination diagnosed EMVI-positive; 5. Tumor amenable to curative resection; 6. 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.No renal disease that would preclude study treatment or follow-up 7. Signed informed consent; able to comply with study and/or follow- up procedures 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.