colorectal cancer
Conditions
Interventions
Neoadjuvant chemoradiotherapy:Long-term radiotherapy and chemotherapy were used to irradiate the primary tumor and high-risk areas with a tumor dose of 50 Gy (2Gy/time × 25 times)
simultaneous administration of capecitabine single-agent chemotherapy during radiotherapy
Neoadjuvant chemoradiotherapy + immunotherapy:Long-term radiotherapy and chemotherapy were used to irradiate the primary tumor and high-risk areas with a tumor dose of 50 Gy (2Gy/time × 25 times)
capecitabine and PD-1 antibody (200mg/3 weeks) were administered simultaneously during radiotherapy. After the radiotherapy, two courses of PD-1 antibody (200mg/3weeks×2)
Sponsors
The First Affiliated Hospital of Naval Medical University, PLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Rectal cancer patients who need APR assessed by MDT and meet the following criteria at the time of enrollment: 1. Patients who are willing to accept neoadjuvant therapy 2. 18 years old = 3.5 x 10^9/L, absolute neutrophil count >= 1.8 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 100g/L; ii. INR = 50mL/min or blood creatinine <= 1.5 times the upper limit of normal. 8. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Past history of malignant colorectal tumors; 2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery; 3. Those who are known to be allergic to drugs such as bevacizumab, capecitabine and PD-L monoclonal antibody; 4. The pathology suggests patients with poorly differentiated adenocarcinoma and signet ring cell carcinoma; 5. The patient is accompanied by any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, hypertension not controlled by drugs, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardium Infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney or metabolic diseases; diseases that affect the life of the patient. 6. Diseases (such as mental illness, etc.) or conditions (such as alcohol or drug abuse, etc.) associated with the patient will increase the patient's risk of receiving experimental drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results; 7. Within 30 days before screening, the patient has received any other experimental drug treatment or participated in another interventional clinical trial; 8. Women who are pregnant or breastfeeding or who intend to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures; 9. Other situations where the researcher judges that the patient is not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete regression rate of tumors;Pathological complete regression rate of tumors;Rate of anus preservation;Rate of rectum preservation; | — |
Countries
China
Contacts
Public ContactZhang Wei
Colorectal Surgery Department, Changhai Hospital, Naval Medical University
Outcome results
None listed