Rectal cancer
Conditions
Interventions
Intensified Treatment Group:After confirming non-response post 2 cycles of CAPOX chemotherapy, eligible patients providing informed consent will be enrolled. They will receive short-course radiotherap
patients will be followed by long-term follow-up and review.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; gender is not limited; 2. Colonoscopy or anal examination, with the lower boundary of the lesion being =9g/dL, white blood cell count (WBC) >= 3.5/4.0×10^9/L, neutrophils >= 1.5×10^9/L, platelets (PLT) >= 100×10^9/L. 2) biochemical examination criteria: Crea and BIL <= 1.0 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×ULN, alkaline phosphatase (ALP) <=2.5×ULN, total bilirubin (Tbil) <=1.5×ULN, normal thyroid function; 8. No history of allergy to 5-FU-based drugs and platinum compounds; 9. No other immune diseases; 10. Patients voluntarily agree to participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed distant metastasis at initial diagnosis or before enrollment; 2. Patients with previous or concurrent other malignancies (including synchronous colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3. Pregnant or breastfeeding women; 4. Patients with severe cardiovascular disease and poorly controlled diabetes; 5. Patients with mental disorders; 6. Patients with severe infections; 7. Patients undergoing thrombolytic/anticoagulant therapy, with bleeding diathesis or coagulation dysfunction; or having experienced aneurysm, stroke, transient ischemic attack, or arteriovenous malformation in the past year; 8. Patients with a history of kidney disease, with proteinuria detected in urine tests, or with significant abnormalities in clinical renal function; 9. Patients with a history of autoimmune diseases, or with severe allergies in the past; 10. Patients allergic to 5-Fu or platinum-based drugs; 11. Patients with severe digestive tract diseases affecting the absorption of oral chemotherapy drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate(CR); | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Incidence of adverse events during treatment;Colostomy rate;Surgical safety indicators;;Quality of life (including anal, urinary system, and sexual function);3 Years overall survival,3y-OS;3 Years distant metastasis-free survival,3y-DMFS;Local regional recurrent-free survival,LRRFS;3 Years Disease-Free Survival, 3y-DFS; | — |
Countries
China
Contacts
Public ContactDeng Xiangbing
West China Hospital of Sichuan University
Outcome results
None listed