NCT05969847Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 23 Jul 2023
- Start date
- 15 Aug 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- 池畔
- Diseases
- Colorectal cancer
- NCT number
- NCT05969847
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 72
- From 15 Aug 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving concomitant treatment with drugs that interact with capecitabine or oxaliplatin (such as flucytosine, phenytoin, and warfarin).
- Uncontrolled active infection or severe concomitant systemic disease.
- Patients who need immunosuppressive therapy for organ transplantation.
Other illness
- Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and adenocarcinoma developed from inflammatory bowel disease.
- Known hypersensitivity to platinum drugs or capecitabine.
- According to the New York Heart Association (NYHA) classification, III or IV heart failure, and angina pectoris have occurred in the past six months.
- Uncontrolled epilepsy or mental illness.
Other
- Metastasis to para-aortic, lateral, or inguinal lymph nodes has been identified.
- Suspected distant metastasis in organs other than para-aortic, lateral, or inguinal lymph nodes is being considered.
- Pregnant or lactating female patients.
- Non-compliance or researchers believe that the patient will not be able to complete the entire trial
Who the study is looking for
- Aged 18-75.
- 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).
- Eastern tumor cooperation group (ECOG) status:0-2.
- American Association of Anesthesiologists (ASA) status: I-III.
- No previous systemic therapy, including chemotherapy, immunotherapy, or radiotherapy for rectal cancer.
- No previous history of pelvic radiotherapy.
- 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.
- Effective contraception during the study.
- Patients are willing and able to comply with the protocol during the study period.
- Patients with written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pan Chi Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.