Clinical trial · Interventional
Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer
Total Neoadjuvant Therapy With Split-course Hypofraction Radiotherapy Combined With CAPOX and Envafolimab Followed by Local Excision for Locally Advanced Very Low Rectal Cancer: an Open-label, Single-arm, Multi-center, Phase II Trial
NCT05969847CI-TRIAL-00068438TRACE-LEnot yet recruitingPhase 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)
Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in a comprehensive neoadjuvant therapy (TNT) protocol. This treatment regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after undergoing TNT, an organ-preserving strategy involving local full-thickness resection was implemented.
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 |
|---|---|---|---|
| CAPOX | Drug | CAPOX Regimen | ALIAS |
| Envafolimab | Drug | — | UNRESOLVED |
| Local excision | Procedure | — | UNRESOLVED |
| split-course hypofraction radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
- description
- Patients diagnosed with locally advanced very low rectal cancer were chosen to undergo a total neoadjuvant therapy (TNT) regimen. This regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after TNT, an organ-preserving strategy involving local full-thickness resection was implemented. Patients who achieve non-clinical complete response are subjected to traditional TME surgery.
- interventionNames
- Radiation: split-course hypofraction radiotherapy
- Drug: CAPOX
- Drug: Envafolimab
- Procedure: Local excision
Primary outcomes (1)
- measure
- Organ preservation
- timeFrame
- 36 months
- description
- The rectum is intact, owing to no radical total mesorectal excision (TME), curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma or a stoma owing to toxicities and/or poor functional outcomes).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18-75. 2. Histopathology confirmed the rectal adenocarcinoma,cT3-4N0 or cT1-4N1-2. The tumor's lower margin ≤ 2cm from the anorectal ring's upper edge (based on MRI measurement). 3. Eastern tumor cooperation group (ECOG) status:0-2. 4. American Association of Anesthesiologists (ASA) status: I-III. 5. No previous systemic therapy, including chemotherapy, immunotherapy, or radiotherapy for rectal cancer. 6. No previous history of pelvic radiotherapy. 7. Sufficient organ function based on the following parameters: An absolute neutrophil count≥ 1.5 × 109 / L, a thrombocyte count ≥ 100 × 109/ L, a glomerular filtration rate (calculated using the Cockcroft-Gault formula) with a creatinine level ≤ 1.5 × ULN or a creatinine clearance \> 50ml/min, and AST and ALT levels ≤ 2.5 × ULN or a total bilirubin level ≤ 1.5 × ULN. 8. Effective contraception during the study. 9. Patients are willing and able to comply with the protocol during the study period. 10. Patients with written informed consent Exclusion Criteria: 1. Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and adenocarcinoma developed from inflammatory bowel disease. 2. Metastasis to para-aortic, lateral, or inguinal lymph nodes has been identified. 3. Suspected distant metastasis in organs other than para-aortic, lateral, or inguinal lymph nodes is being considered. 4. Known hypersensitivity to platinum drugs or capecitabine. 5. Patients receiving concomitant treatment with drugs that interact with capecitabine or oxaliplatin (such as flucytosine, phenytoin, and warfarin). 6. According to the New York Heart Association (NYHA) classification, III or IV heart failure, and angina pectoris have occurred in the past six months. 7. Uncontrolled active infection or severe concomitant systemic disease. 8. Patients who need immunosuppressive therapy for organ transplantation. 9. Uncontrolled epilepsy or mental illness. 10. Pregnant or lactating female patients. 11. Non-compliance or researchers believe that the patient will not be able to complete the entire trial
References
Publications (0)
Data not yet available
No reference posted for this study.