Rectal cancer
Conditions
Interventions
Gold Standard:pCR
Index test:the radiomic features, the characteristics of gut microbiota, and ctDNA features
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: =18 years old, gender unrestricted. 2. ECOG (Eastern Cooperative Oncology Group) performance status: 0-1. 3. Pathological diagnostic criteria: diagnosed as rectal adenocarcinoma through histopathological and/or cytological examination. 4. Clinical diagnostic criteria: baseline rectal MRI confirms clinical staging as T3-T4 or any T stage with N+ (8th edition AJCC staging system) and baseline examination indicates no distant metastasis. 5. Digital rectal examination or colonoscopy confirms that the lower margin of the tumor is =15 cm from the anal verge. 6. No other severe medical comorbidities. 7. Conscious, able to cooperate with positioning, setup, and treatment. 8. The subject voluntarily joins this study, signs the informed consent form, has good compliance, and is willing to accept follow-up. 9. Plans to undergo radical rectal cancer surgery in this hospital. 10. No history of pelvic radiotherapy. 11. Important organs or functions meet the following requirements (use of any blood components or growth factors to correct results within 2 weeks before examination is not allowed): able to control bowel and urinary functions autonomously to facilitate radiotherapy preparation; absolute neutrophil count (ANC) =1.5×10?/L, platelets =100×10?/L, hemoglobin =10g/dL; serum albumin =3.0 g/dL, total bilirubin =ULN (upper limit of normal), ALT, AST, and/or ALP =2.5 ×ULN, serum creatinine =ULN; international normalized ratio (INR) and activated partial thromboplastin time (APTT) =ULN. 12. Women of childbearing potential must have a negative serum HCG test result within 7 days prior to enrollment and voluntarily use appropriate contraception during the observation period and for 8 weeks after the last administration of chemoradiotherapy; for men, they must have undergone surgical sterilization or agree to use appropriate contraception during the observation period and for 8 weeks after the last administration of chemoradiotherapy.
Exclusion criteria
Exclusion criteria: 1) ECOG = 2, or KPS score = 70; 2) Age > 75 years old; 3) Distant metastasis; 4) Previous or concurrent malignancy, excluding adequately treated basal cell carcinoma of the skin, early-stage thyroid cancer, breast cancer with excellent prognosis, etc.; 5) Known allergy to capecitabine; 6) Recurrent rectal cancer; 7) Uncontrolled medical conditions: current active infection (NCI-CTCAE grade > 2); clinically significant cardiac disease; New York Heart Association (NYHA) = class II congestive heart failure; unstable symptomatic arrhythmias or peripheral vascular disease = grade II; myocardial infarction or cerebrovascular accident within 6 months prior to enrollment; 8) Need for emergency surgery due to intestinal obstruction, perforation, bleeding, etc.; 9) Gastrointestinal disorders causing impaired capecitabine absorption, such as short bowel syndrome, inflammatory bowel disease, etc.; 10) Concomitant unresectable intestinal disease; 11) Predicted survival of less than 3 months; 12) Contraindications or relative contraindications to MRI examination, including allergy to MRI contrast agents; 13) Lactating, pregnant, or fertile women without adequate contraception; 14) Psychiatric or medical conditions rendering the patient unable to give informed consent; 15) Poor compliance or deemed unsuitable for the clinical trial by the investigator; 16) Received anti-tumor treatment prior to screening; 17) History of immune deficiency, including HIV positive status, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation; 18) Active hepatitis B (HbsAg positive, and HBV-DNA = 2500 copies/ml or 500 IU/ml) or hepatitis C (anti-HCV positive, and HCV-RNA above the detection limit of the assay); co-infection with hepatitis B and hepatitis C (HbsAg or HbcAb positive and HCV antibody positive).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, SE;Specificity, SP;Positive predicative value;negative predictive value;Accuracy; | — |
Countries
China
Contacts
Public Contactweihu wang
Beijing Cancer Hospital
Outcome results
None listed