Status and phase
Conditions
Treatments
About
The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are:
Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Recurrent rectal cancer
Microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
The patient has had other malignancies in the past 5 years (in addition to properly treated basal cell carcinoma and skin squamous cell carcinoma)
The patient has had arterial embolic diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.
Have received other types of anti-tumor or experimental therapy
The patient is a pregnant or lactating woman
The patient has other diseases or mental disorders that may affect the patient's participation in this study
Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy or VEGFR TKI therapy.
Major surgical procedures were performed/received within 4 weeks prior to the first administration of the study drug or the side effects of which have not yet recovered, live vaccination, immunotherapy, and radiotherapy within 2 weeks.
Study patients who had received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week before the first administration of the drug.
Known allergy to the investigational drug and its components
Active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis.
Have any clinical problems beyond your control, including but not limited to:
a persistent or active (severe) infection b Poorly controlled hypertension (persistent blood pressure greater than 150/90 MMHG) c Poorly controlled diabetes mellitus d Heart disease (Grade III/IV congestive heart failure or heart block as defined by the Heart Society of New York) e Have or suspect an autoimmune disease, or a history of autoimmune disease or syndromes requiring treatment with a steroid/immunosuppressive system, such as hypophysitis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.;
Other severe, acute, or chronic medical conditions or abnormalities in laboratory tests that the investigator determines may increase the risk associated with study participation or may interfere with the interpretation of the study results.
Primary purpose
Allocation
Interventional model
Masking
472 participants in 2 patient groups
Loading...
Central trial contact
WU AI WEN, M.D.; DONG QIU SHI
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal