locally advanced rectal cancer
Conditions
Interventions
Trial Group:Rilavapu a injection (1800mg, intravenous infusion, Q3W) combined with CAPOX regimen (Oxaliplatin 130mg/m2, Day 1
Capecitabine 1000mg/m2, Days 1-14), 4 cycles preoperatively
surgery performed 4-6 weeks after completion, postoperative regimen selected by investigator.
Sponsors
Xijing Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and is willing to cooperate with follow-up visits. 2. Age >= 18 years, male or female. 3. Histopathological examination confirms rectal adenocarcinoma. 4. Imaging (CT/MRI) confirms clinical stage T3-4N0 or T1-T3N+. 5. ECOG performance status: 0–1. 6. No involvement of the levator ani muscle; no tumor deposits; MRF negative (MRF-). 7. Distance from the lower edge of the tumor to the anal verge = 90 g/L; • Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; • Platelet count (PLT) >= 80 × 10^9/L. 2) Biochemistry: • Total bilirubin (TBIL) = 60 mL/min. 3) Doppler echocardiography: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%). 9. Female patients of childbearing potential must agree to use contraceptive measures (such as intrauterine device, contraceptive pill, or condom) during the study period and within 6 months after the study completion; a negative serum or urine pregnancy test within 7 days prior to enrollment is required, and they must be non-lactating. Male patients must agree to use contraceptive measures during the study period and within 6 months after the study completion. 10. The patient voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other malignancies occurred within the past 5 years or currently co-existing, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)]; 2. MSI-H or dMMR, HER2 overexpression, Claudin18.2 positive; 3. Patients with a high risk of bleeding or fistula due to significant tumor invasion into adjacent organs (major arteries or trachea); 4. Subjects with diseases requiring systemic treatment with glucocorticoids (>10 mg prednisone equivalent dose per day) or other immunosuppressive drugs within 14 days before the start of study treatment. In the absence of active autoimmune disease, the use of inhaled or topical steroids at >10 mg daily prednisone equivalent dose and adrenal replacement steroid doses is permitted; 5. Patients with significant malnutrition. Patients receiving intravenous nutritional support or requiring hospitalization for continuous infusion therapy are excluded. Patients with well-controlled nutrition for >=28 days may be enrolled; 6. Participants who received live/attenuated vaccines within 30 days after the first treatment; 7. Unresolved toxicity higher than CTCAE Grade 2 caused by any prior treatment, excluding alopecia and oxaliplatin-induced neuropathy =150 mmHg, diastolic blood pressure >=100 mmHg); (2) Myocardial ischemia or myocardial infarction above Grade I, arrhythmias (including QTc >=480 ms), and congestive heart failure >=Grade 2 (New York Heart Association [NYHA] classification); (3) Severe or uncontrolled diseases or active infections (>=CTC infection), which the investigator believes will increase the risk associated with study participation or study drug administration, or affect the subject's ability to receive the study drug; (4) Renal failure requiring hemodialysis or peritoneal dialysis; (5) History of immunodeficiency, including HIV positivity or other acquired/congenital immunodeficiency diseases, or history of organ transplantation; (6) Poor glycemic control in diabetic patients (fasting blood glucose [FBG] >10 mmol/L); subjects with active, known, or suspected autoimmune diseases. Subjects with type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) may be enrolled; (7) Patients with seizures requiring treatment; (8) Subjects with a history of interstitial lung disease, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; 10. Patients with current gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those judged by the investigator to be at risk of gastrointestinal bleeding, perforation, or obstruction; 11. Patients who underwent surgical procedures, incisional biops
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival (EFS);R0 Resection Rate;Objective Response Rate (ORR);Sphincter Preservation Rate;Overall Survival (OS);Safety Outcomes (including adverse events and perioperative complications); | — |
Countries
China
Contacts
Public ContactFeng Fan
Xijing Hospital, Air Force Medical University
Outcome results
None listed