Clinical trial · Interventional
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
A Prospective, Multicenter, Randomized Controlled Trial of Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
NCT04543695CI-TRIAL-00075422unknownPhase 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)
A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent Chemoradiotherapy | Combination Product | — | UNRESOLVED |
| mFOLFOX | Drug | — | UNRESOLVED |
| TME | Procedure | — | UNRESOLVED |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- adjuvant chemotherapy group
- description
- concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
- interventionNames
- Combination Product: Concurrent Chemoradiotherapy
- Drug: XELOX
- Drug: mFOLFOX
- Procedure: TME
- type
- EXPERIMENTAL
- label
- consolidation chemotherapy group (CNCT group)
- description
- concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group)
- interventionNames
- Combination Product: Concurrent Chemoradiotherapy
- Drug: XELOX
- Drug: mFOLFOX
- Procedure: TME
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: 1. 18-75 years old, regardless of gender 2. Histologically confirmed rectal adenocarcinoma; 3. Up to 12 cm above the anal verge on the basis of rigid rectoscopy. 4. MRI of the rectum is acceptable; 5. Patients in stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement. 6. ECOG score 0-1 or KPS score ≥80. Exclusion Criteria: 1. History of malignant tumor in other parts; 2. Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs; 3. During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year; 4. History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal; 5. History of digestive tract fistula, perforation or severe ulcer; 6. Active infection is present; Clinically obvious heart disease; New York heart association (NYHA) of Ⅱ level or congestive heart failure; Unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.