Rectum cancer
Conditions
Interventions
Sponsors
Sichuan University West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with locally advanced rectal cancer by imaging and histopathology and/or cytology, specifically: cT3-4, any N, M0 (according to AJCC 8th Edition); 2. Tumor lower margin =9 g/dL (no blood transfusion within 14 days before enrollment), absolute neutrophil count (ANC) >=1.5 × 10^9/L, white blood cell count >=3.0 × 10^9/L (no granulocyte colony-stimulating factor use within 14 days before enrollment), platelets >=75 × 10^9/L (no IL-11 or TPO use within 14 days before enrollment). (2).Biochemistry: Serum total bilirubin (TBIL) =60 mL/min (Cockcroft-Gault formula), serum albumin >=25 g/L (2.5 g/dL). (3).Coagulation: International normalized ratio (INR) or prothrombin time (PT) =50% by echocardiography; 11.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and be willing to use appropriate contraception during the trial and for at least 3 months after the last dose. Women of childbearing potential are required to use effective contraception during the study and for at least 6 months after the last dose of chemotherapy. Female participants must not breastfeed and must not donate/extract eggs within 60 days after the last dose. Male participants must be surgically sterile or agree to use appropriate contraception during the trial and for at least 3 months after the last dose; 12.Subjects voluntarily participate in the study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of dMMR or MSI-H by pathological immunohistochemistry or genetic testing; 2.Evidence of peritoneal or multiple visceral metastatic disease (distant metastasis ruled out by thoracic/abdominal CT, bone scan, or MRI [if clinical signs suggest bone lesions]); 3.History of concurrent or other malignancies within 5 years prior to treatment initiation, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; 4.Allergy to any investigational drug or its excipients, history of severe allergies, or contraindications to the investigational drugs; 5.Clinically significant upper gastrointestinal bleeding =30 days before enrollment or randomization; 6.Idiopathic pulmonary fibrosis, drug-induced pneumonia, active tuberculosis infection, or CT-confirmed active pneumonia; interstitial lung disease requiring steroid treatment; 7.Autoimmune or inflammatory diseases (including IBD such as Crohn's disease, ulcerative colitis, or diverticulitis, SLE, sarcoidosis syndrome, tuberculosis, Wegener's syndrome, myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, glomerulonephritis, nephrotic syndrome, Fanconi syndrome, or renal tubular acidosis) requiring immunosuppressants in the past 2 years prior to treatment initiation. Exceptions: type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); 8.History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or organ transplantation. Known positive human immunodeficiency virus (HIV) test (HIV 1/2 antibody positive); 9.Active hepatitis B (HBV surface antigen [HBsAg] positive) or active hepatitis C virus infection. Patients with past or currently stable HBV or HCV infection may participate; 10.Systemic use of glucocorticoids or immunosuppressants within 2 weeks prior to trial initiation (Note: Inhaled corticosteroids and topical steroids are permitted). Note: Inhaled or topical steroids, or adrenal replacement therapy with prednisone =10 mg/day equivalent are allowed in the absence of active autoimmune disease. Short-term (=150 mmHg or diastolic BP >=100 mmHg);Myocardial ischemia (grade II or above), myocardial infarction, acute coronary syndrome (within 6 months), arrhythmias (including QTc >=480 ms, atrial fibrillation), or uncontrolled angina;Grade III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) 10 mmol/L);Urine protein >=++ on urinalysis or 24-hour urine protein >1.0 g. 12.Abnormal coagulation (INR >1.5 or APTT >1.5 × ULN), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy. Known hereditary or acquired bleeding or thrombotic tendencies, such as hemophilia, coagulation disord
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate (including clinical complete response rate, pathologic complete response rate, and the rate of TRG0+TRG1a); | — |
Secondary
| Measure | Time frame |
|---|---|
| Downstaging rate;Sphincter-preserving rate;Surgical resection rate;Objective Response Rate;Disease-Free Survival;Overall Survival;1-, 2-, and 3-year survival rates;Duration of sustained remission in patients with clinical complete remission;Possible adverse events; | — |
Countries
China
Contacts
Public ContactZhiping Li
Sichuan University West China Hospital
Outcome results
None listed