rectal cancer
Conditions
Interventions
Neoadjuvant chemotherapy group (experimental group):Neoadjuvant chemotherapy uses the XELOX regimen for 4 cycles. Specific doses: Oxaliplatin 130 mg/m2, day 1, intravenous infusion
Capecitabine 1000 mg/m2, twice daily, days 1-14, oral administration
every 3 weeks. During chemotherapy, monitor toxic side effects (CTCAE 5.0) each cycle. TME surgery is performed 2-4 weeks after the end of chemotherapy.
Surgical group (control group):Proceed directly with TME surgery.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old; no gender restrictions. 2. Diagnosis: Rectal adenocarcinoma confirmed by electronic colonoscopy biopsy, with immunohistochemistry and/or genetic testing showing pMMR/MSS. 3. Tumor characteristics assessed by chest and abdominal CT, rectal ultrasound, and MRI as follows: (1) Distance from the lower edge of tumor to anal verge measured by digital rectal examination or MRI: 5cm 1mm), EMVI negative (-); (4) Lateral lymph nodes negative and short diameter =9g/dL, WBC >=3.5/4.0×10^9/L, neutrophils >=1.5×10^9/L, PLT >=100×10^9/L. (2) Renal function tests: Crea and BIL <=1.0×upper limit of normal (ULN). (3) Liver function tests: ALT and AST <=2.5×ULN, alkaline phosphatase (ALP) <=2.5×ULN, total bilirubin (Tbil) <=1.5×ULN. 7. No history of allergies to 5-Fu or platinum drugs. 8. Informed consent: Patients fully understand the purpose, content, potential benefits, and risks of this study, voluntarily sign written informed consent to participate, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients considered to have Lynch syndrome; 2.Patients who have had other malignant tumors (including synchronous colorectal cancer) within the past 5 years or simultaneously, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3.Patients with complications requiring emergency surgery such as intestinal obstruction, bowel perforation, or active massive bleeding; 4.Patients who have previously received pelvic radiotherapy; 5.Presence of any medical or anatomical factors that may hinder the safe performance of total mesorectal excision; 6.Pregnant or breastfeeding women; 7.Participants who have participated in another clinical trial within 4 weeks before the start of treatment; 8.Any other conditions that, in the investigator's judgment, may increase study risk, interfere with study results, or affect the patient's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Tumor downstaging rate;3-year metastasis-free survival;3-year overall survival;local recurrence rate;Perioperative complication rate;Postoperative pathological features;Chemotherapy side effects; | — |
Countries
China
Contacts
Public ContactWenjian Meng
West China Hospital, Sichuan University
Outcome results
None listed