Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study
This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer
• The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance；
• Age ≥18 years and ≤75 years, without gender restriction.
• Histopathologically confirmed locally advanced rectal adenocarcinoma.
• Participants who are not suitable for standard therapy due to intolerable toxicity, lack of standard therapy, or refusal of standard therapy.
• Hematological parameters at baseline\* (within 7 days prior to the first dose of study drug) must meet the following criteria: • Hemoglobin ≥90 g/L • Absolute neutrophil count (ANC) ≥1.5×10\^9/L • Platelet count ≥100×10\^9/L • Eosinophils ≤1.5×upper limit of normal (ULN). \*Participants may not have received blood products (including red cell suspensions, plateletpheresis, cryoprecipitate), erythropoietin, or colony-stimulating factor supportive treatment within 7 days prior to blood sampling.
• Serum biochemical tests at baseline (within 7 days prior to the first dose) must meet the following criteria: • Total bilirubin ≤1.5×ULN (if total bilirubin \>1.5×ULN, direct bilirubin ≤ULN is acceptable for inclusion). • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN. • Serum creatinine ≤1.5×ULN or creatinine clearance (CCr) ≥45 mL/min, calculated using the Cockcroft-Gault formula (Appendix 4) using actual body weight. • Albumin ≥30 g/L.
• Coagulation tests at baseline (within 7 days prior to the first dose) must meet the following criteria: • International normalized ratio (INR) ≤1.5×ULN (≤3×ULN if on stable anticoagulant therapy). • Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN (≤3×ULN if on stable anticoagulant therapy).
• Urinalysis at baseline (within 7 days prior to the first dose) must meet the following criteria: urine protein (UPRO) \<2+ or 24-hour urinary protein \<1 g.
• At least one measurable lesion according to RECIST v1.1 (solid tumors) criteria.
⁃ Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
⁃ Expected survival ≥3 months.
⁃ Women of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the end of treatment.