The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined with Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.
Subjects participate in the study need to sign the informed consent, and demonstrate good compliance.
Age: 18~75 years old.
Histopathologically confirmed rectal adenocarcinoma.
Locally advanced rectal cancer, determined at baseline.
Within 4 weeks prior to treatment, subjects must not have received radiotherapy, surgery, chemotherapy, immunotherapy for tumors, molecular targeted therapies, or other investigational drugs.
microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
Distant metastasis
Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (bleeding > 30ml within 3 months), hematemesis, black stool, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), etc. Treatment of venous/venous thrombotic events within the first 6 months, such as cerebrovascular accidents (including transient brain lesions) Ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Or need to use warfarin or Long-term anticoagulant therapy with heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or chlorine) is required Picogrel ≥75 mg/day).
Parallel
Concurrent Chemoradiotherapy（Radiation + Capecitabine）
RadiationCapecitabine 825 mg/m\^2 Po BlD, Monday-Friday, on days of radiation treatment only, throughout the duration of RT Radiation：45-50Gy/25fractions/5 weeks，5fractions/week
irinotecan hydrochloride liposome injection
DrugIrinotecan hydrochloride liposome injection (50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
Oxaliplatin
DrugOxaliplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
5-FU
Drug5-FU (2400mg/m\^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.
Pathological complete response rate
To evaluate the efficacy of anti-tumor
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Peking University Cancer Hospital & Institute
Lead sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator
