Rectal Cancer
Conditions
Interventions
Super-Minimally Invasive Organ-Preserving Surgery Group:None
Total mesorectal excision Group:None
Sponsors
The First Medical Centre of the PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed rectal adenocarcinoma meeting the following criteria: (1) Clinical stage cT2N+M0 or cT3-4N0-2M0; (2) Tumour distance from the anus <=10cm; 2. ECOG score 0-1 points; 3. Consent for researchers to utilise blood, stool samples, and tissue pathology sections for study purposes during the trial period; 4. Age: 18–80 years; 5. General condition permitting tolerance of endoscopic treatment and local excision surgery; 6. Patient and family members capable of understanding the study protocol, voluntarily participating in the research, and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Current or past history of active malignancies other than rectal cancer; 2. Patients with confirmed distant organ metastases or peritoneal seeding at diagnosis; 3. Major surgical procedures within 4 weeks prior to study treatment initiation; 4. Presence of perforation, haemorrhage, or obstruction prior to neoadjuvant chemoradiotherapy; 5. Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases: 6. Severe concomitant diseases with a survival prognosis of <5 years; 7. Allergy to any component of the study medication; 8. Current or past moderate to severe hepatic or renal impairment: 9. Patients scheduled for, or who have previously undergone, organ transplantation or allogeneic bone marrow transplantation; 10. Patients with congenital or acquired immunodeficiency (e.g., HIV infection); 11. History of uncontrolled epilepsy, central nervous system disorders, or psychiatric conditions, where the investigator deems clinical severity to impede informed consent or compromise oral medication adherence; 12. Patients with other factors deemed by the investigator to potentially influence study outcomes or necessitate premature termination of participation, such as alcohol abuse, substance misuse, concomitant treatment for other serious conditions (including psychiatric disorders), severe laboratory abnormalities, or familial/social circumstances compromising patient safety; 13. Subjects deemed ineligible for this study by the investigator for other reasons; 14. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumour recurrence rate;Disease Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;en bloc rate;operation time;Incidence of complications;LARS score;Quality of Life Score;spend; | — |
Countries
China
Contacts
Public ContactLinghu Enqiang
The First Medical Centre of the PLA General Hospital
Outcome results
None listed