Pathologically confirmed rectal adenocarcinoma (non-specific and specific types, including mucinous adenocarcinoma, signet ring cell carcinoma, serrated adenocarcinoma, micropapillary carcinoma, medullary carcinoma, and cribriform comedo adenocarcinoma)
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed rectal adenocarcinoma (non-specific and specific types, including mucinous adenocarcinoma, signet ring cell carcinoma, serrated adenocarcinoma, micropapillary carcinoma, medullary carcinoma, and cribriform comedo adenocarcinoma); patients with resectable rectal cancer whose preoperative imaging stage is T3 stage and/or N+ or T4 stage patients, reassessment of resectability must be performed after neoadjuvant therapy. 2.Age >= 18 years, gender not limited, ECOG score 0-2 points; 3.Physical condition and organ function permitting to undergo major abdominal surgery; 4.The researchers agreed to use blood, stool, and pathological sections during the study. 5.Major organ functions must meet the following requirements (laboratory test values ??must meet the following standards within 7 days prior to enrollment): Complete blood count (no blood transfusion, no use of granulocyte colony-stimulating factor, and no use of corrective drugs within 14 days prior to screening): a) Neutrophils >= 1.5 × 10?/L; b) Platelets >= 75 × 10?/L; c) Hemoglobin >= 90 g/L; Biochemical tests (no albumin transfusion within 14 days prior to screening): a) Serum creatinine 50 mL/min; b) Serum total bilirubin <= 1.5 × ULN; c) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN; Coagulation function: International normalized ratio (INR) <= 2.3 or prothrombin time (PT) exceeding the normal control range by <= 6 seconds. 6.Recruited patients regardless of their programmed death-ligand 1 (PD-L1) expression levels.
Exclusion criteria
Exclusion criteria: 1.The tumor has distant metastases or peritoneal metastases confirmed by laparoscopy. 2.Patients with other severe immunosuppressive diseases or other malignant tumors; 3.Are there any conditions that affect capecitabine absorption in the intestine?; 4.Severe, uncontrolled recurrent infections, or other severe, uncontrolled comorbidities; severe mental illness; severe respiratory illness; severe hepatic or renal insufficiency; history of unstable angina or myocardial infarction within the past 6 months; history of cerebral infarction or cerebral hemorrhage within the past 6 months; continuous use of glucocorticoids (excluding topical application) within the past month. 5.Researchers determined that the patient had other comorbidities that could endanger patient safety or potentially affect the completion of the study. 6.Currently or previously received any other investigational medication or immunotherapy; 7.Suffering from malignant tumors in other parts of the body within five years; 8.The patient is a pregnant or breastfeeding woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Complete surgical resection rate;Objective response rate;Clinical decline rate (T and /or N decline);Major Pathological Response; | — |
Countries
China
Contacts
Public ContactLi Yongxiang
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed