rectal cancer
Conditions
Interventions
Long-course Chemoradiotherapy Group:Long-course radiotherapy + concurrent tislelizumab + CAPOX chemotherapy for 2 cycles ? tislelizumab + CAPOX chemotherapy for 4 cycles ? surgery or watch-and-wait wi
Short-course Radiotherapy Group:Short-course radiotherapy ? tislelizumab + CAPOX chemotherapy for 6 cycles ? surgery or watch-and-wait within 4-8 weeks after the last dose of capecitabine
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily provide written informed consent. 2. Age >= 18 years and = 1.5 × 10?/L (1,500/mm³); ii. Platelet count >= 100 × 10?/L (100,000/mm³); iii. Hemoglobin >= 90 g/L. b) Renal: i. Estimated creatinine clearance (CrCl) >= 50 mL/min. * CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = {(140 - Age) × Weight (kg) × 0.85} / (Serum Creatinine (mg/dL) × 72) ii. Urine protein = 28 g/L. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 12. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to study treatment (if urine pregnancy test results cannot be confirmed as negative, a serum pregnancy test is required, with serum pregnancy test results taking precedence). If a female subject of childbearing potential is sexually active with a non-sterilized male partner, the subject must use an acceptable method of contraception starting from screening and must agree to continue using contraception for 120 days after the last dose of study drug; whether to discontinue contraception after this time point should be discussed with the investigator. Periodic abstinence and calendar methods are not acceptable methods of contraception. a) A female of childbearing potential is a female who has not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or is not postmenopausal (postmenopausal is defined as at least 12 consecutive months of amenorrhea without alternative medical causes, with serum follicle-stimulating hormone levels within the laboratory reference range for postmenopausal women); b) Highly effective contraception refers to methods with low failure rates (i
Exclusion criteria
Exclusion criteria: 1. Presence of suspected metastatic lesions or locally advanced unresectable disease, regardless of disease stage. 2. Subjects with other malignancies within 5 years prior to enrollment, excluding rectal cancer. Subjects with other malignancies cured by local treatment are not excluded, such as basal or squamous cell skin cancer, superficial bladder cancer, ductal carcinoma in situ of the breast, etc. 3. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study. 4. Presence of intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgical intervention. 5. Multiple primary rectal cancers. 6. History of pelvic and abdominal radiotherapy. 7. Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption. 8. Prior receipt of any systemic or local anti-tumor treatment for locally advanced rectal cancer, including radical surgery, chemotherapy, radiotherapy, immunotherapy (including immune checkpoint inhibitors, immune checkpoint agonists, cellular immunotherapy, or any treatment targeting tumor immune mechanisms), biological agents, small molecule targeted therapy, etc. 9. Receipt of non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, tumor necrosis factor, etc., excluding IL-11 for treatment of thrombocytopenia) within 2 weeks prior to study treatment; receipt of Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 1 week prior to study treatment. 10. Active autoimmune disease requiring systemic treatment within the past two years (such as use of disease-modifying agents, corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. 11. History of non-infectious pneumonia requiring systemic corticosteroid therapy, or current history of interstitial lung disease. 12. History of severe bleeding tendency or coagulation dysfunction; subjects with prior or current requirement for long-term anticoagulant therapy (e.g., atrial fibrillation patients with CHADS2 score >= 2). 13. Currently uncontrolled comorbid conditions, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements or affect the subject's ability to provide written informed consent. 14. Prior history of myocarditis, cardiomyopathy, or malignant arrhythmia. Within 12 months prior to study treatment, history of unstable angina requiring hospitalization, congestive heart failure, or vascular disease (e.g., aortic aneurysm requiring surgical repair or peripheral venous thrombosis), or other cardiac impairment that may affect safety evaluation of study drug (e.g., poorly controlled arrhythmia, myocardial infarction or ischemia); within 6 months prior to study treatment, history of esophageal and gastric varices, severe ulceration, unhealed wounds, gastrointestinal perforation, abdominal fistula, intestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding; within 6 months prior to study treatment, occurrence of any arterial thromboembolic event, venous thromboembolism of Gr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year event-free survival (EFS) rate;3-year overall survival (OS) rate; | — |
Countries
China
Contacts
Public ContactWenjun Xiong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed