Rectal Cancer
Conditions
Interventions
endoscopic full thickness resection(EFTR) Group:none
total mesorectal excision(TME) Group:none
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old=1.5×10^9/L; b) platelets >=75×10^9/L; c) haemoglobin >=90g/L; (2) Biochemical tests: (no albumin infusion within 14 days prior to screening): a) Blood creatinine 50 mL/min; b) Serum total bilirubin <=1.5 × ULN; c) Glutamine aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 × ULN; (3) Coagulation: a) International Normalised Ratio (INR) <= 2.3 or Prothrombin Time (PT) <= 6 seconds above the range of normal control.
Exclusion criteria
Exclusion criteria: 1. Current or previous active malignancy other than rectal cancer; 2. Patients with distant organ metastases or peritoneal implants at the time of diagnosis; 3. Major surgical treatment within 4 weeks prior to the start of study treatment; 4. Presence of perforation, haemorrhage, or obstruction prior to neoadjuvant radiotherapy; 5. Persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant disease; 6. Severe concomitant disease that renders survival < 5 years; 7. Hypersensitivity to any of the medication components used in the study; 8. Present or previous moderate or severe hepatic or renal impairment; 9. Patients who are preparing for or have previously undergone organ or allogeneic bone marrow transplantation; 10. Patients with congenital or acquired immune deficiency (e.g., HIV-infected); 11. Patients with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders whose clinical severity, in the judgement of the investigator, prevents the signing of an informed consent form or affects the patient's adherence to oral medication; 12. Patients who, in the judgement of the investigator, have other factors that may affect the results of the study or cause this study to be forced to be terminated in midstream, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) that require comorbid treatment, serious laboratory test abnormalities, concomitant family or social factors, etc., that would affect the safety of the patient; 13. Subjects who are judged by the investigator to be unsuitable for this study for other reasons; 14. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free interval;Pathological Complete Remission;overall survival;Local recurrence;Complete clinical remission;Pain classification;Bleeding classification;Gastrointestinal adverse events;Length of stay;treatment cost;quality of life; | — |
Countries
China
Contacts
Public ContactEnqiang Linghu
Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed