Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
- Conditions
- Locally Advanced Rectal Cancer
- Registration Number
- NCT05086627
- Lead Sponsor
- Hebei Medical University Fourth Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Patients or their family members agree to participate in the study and sign the informed<br>consent form;<br><br>Patients = 18 and =75 years old, male or female;<br><br>ECOG performance status of 0 or 1;<br><br>Patients with histologically confirmed rectal adenocarcinoma;<br><br>The clinical diagnosis of chest CT, abdominal and pelvic enhanced MRI was T1-2N+M0 and<br>cT3-4NanyM0 (the T and N stage was based on pelvic enhanced MRI+DWI, M stage was<br>determined by liver enhanced MRI+DWI and chest CT, and if necessary, PET-CT was used);<br><br>The distance between the lower edge of the tumor and the anal edge is less than or equal<br>to 10 cm;<br><br>No history of immune system diseases;<br><br>No history of immunodeficiency, including HIV positive;<br><br>No history of other malignancies;<br><br>No history of myocarditis;<br><br>No history of severe cardiovascular and cerebrovascular diseases;<br><br>No history of thyroid dysfunction;<br><br>No history of liver and kidney diseases;<br><br>No history of mental illness, no history of Infectious diseases;<br><br>No history of organ transplantation or allogeneic bone marrow transplantation;<br><br>There is no history of other systemic diseases other than the above diseases;<br><br>Voluntarily accept the neoadjuvant treatment scheme of radiotherapy, sequential<br>chemotherapy / chemotherapy combined with immunotherapy;<br><br>Swallowing pills normally;<br><br>Rectal cancer without radiotherapy, chemotherapy, surgery, Chinese medicine anti-tumor<br>treatment, etc.;<br><br>Surgical treatment is planned after neoadjuvant treatment.<br><br>Exclusion Criteria:<br><br>Patients who do not meet the above inclusion criteria;<br><br>Documented history of allergy to study drugs, including any component of Tislelizumab,<br>capecitabine, oxaliplatin and other platinum drugs;<br><br>Patients who need to be treated with corticosteroid (dose equivalent to prednisone of >10<br>mg/day) or other immunosuppressive agents within 2 weeks prior to study drug<br>administration; Major surgery or severe trauma within 4 weeks before the first use of the<br>study drug;<br><br>Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study<br>drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms<br>of infection within 14 days prior to the first use of the study drug, or oral or<br>intravenous antibiotic therapy, except for prophylactic use of antibiotics;<br><br>Female patients who is pregnant or breastfeeding;<br><br>Patients who refuse to sign informed consent by themselves or their authorized persons;<br><br>Patients with poor cognitive ability, unable to answer questions, unable to fill in<br>questionnaires or mental disorders;<br><br>Patients considered unsuitable for the study by the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response rate
- Secondary Outcome Measures
Name Time Method major pathologic response (TRG0+TRG1);3-year PFS;3-year OS;Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]