Colorectal cancer
Conditions
Interventions
Experimental Group:Irinotecan Liposome Combined with Capecitabine as Neoadjuvant Chemoradiotherapy for Locally Advanced Colorectal Cancer
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age>= 18 years and = 70; 7.No prior chemotherapy or any other anti-tumor treatment before enrollment; 8.Bone marrow function: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelets (PLT) >=100 × 10^9/L, hemoglobin (Hb) >= 90 g/L, white blood cells (WBC) =>= 3.0 × 10^9/L; 9.Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) =60 ml/min (calculated by Cockroft-Gault), urine protein < 2+; 11.Coagulation function: International normalized ratio (INR) <= 1.5 times the upper limit of normal (ULN), activated partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal (ULN); 12.The patient and/or legal representative understand the study and voluntarily agree to participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients who have had other malignancies within the past 5 years (except for cured in situ cancer and skin basal cell carcinoma); 2.Patients with uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, which the investigator judges may interfere with the ability to provide informed consent or affect the patient's adherence to oral medication; 3.Clinically significant (i.e., active) cardiovascular disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) Class ? or more severe congestive heart failure, or significant arrhythmias requiring medical intervention, or a history of myocardial infarction within the past 12 months; 4.Patients who have undergone organ transplantation and require immunosuppressive therapy; 5.Patients with severe uncontrolled recurrent infections or other significant uncontrolled comorbidities; 6.Patients with severe gastrointestinal disorders (including active bleeding, more than Grade 1 obstruction, more than Grade 1 diarrhea, or gastrointestinal perforation); 7.Patients who have undergone laparotomy, thoracotomy, or bowel resection within 28 days before enrollment; 8.Patients with interstitial pneumonia or pulmonary fibrosis; 9.Patients known to be allergic to or intolerant of the study drugs or their excipients; 10.Patients with a history of pulmonary hemorrhage/hemoptysis = Grade 2 (defined as at least 2.5 mL of bright red blood) within the past month before enrollment; 11.Patients with a history of arterial embolism, severe bleeding (excluding bleeding caused by surgery), or existing thrombosis or tendency to severe bleeding within the past 6 months before enrollment; 12.Patients with central nervous system metastasis; 13.Patients with serum albumin <= 3 g/dL; 14.Patients using strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1; 15.Pregnant or breastfeeding women, and women of childbearing age who refuse to take appropriate contraceptive measures during the trial; 16.Patients who have participated in other studies within 30 days before the first dose of the study drug; 17.Patients whom the investigator judges to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response;Progression Free Survival;Surgical Complications;3-year Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactXiushen Wang
Henan Cancer Hospital
Outcome results
None listed