Status:
RECRUITING
Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer.
Lead Sponsor:
Peking University Cancer Hospital & Institute
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 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.
- No prior systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
- Expected survival ≥ 12 months.
- Adequate bone marrow function (In the absence of blood transfusion within 14 days, correction with granulocyte colony-stimulating factor or other hematopoietic stimulating factor was not used within 7 days prior to laboratory examination) :
- ①Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count ≥100×10\^9/L, Hemoglobin (Hb) ≥9g/dL.
- ② Liver function: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, liver metastasis, AST and ALT≤5×ULN.
- ③ Renal function: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
- ④International Normalized Ratio (INR) ≤ 1.5 ULN, Prothrombin time and activated partial thromboplastin time (APTT) ≤ 1.5 ULN
- Microsatellite Stability (MSS) or proficient MisMatch Repair (pMMR).
Exclusion
- 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).
- During screening, tumors were found to invade large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava that there was a risk of major bleeding by the investigator judged.
- Active heart disease, including myocardial infarction, severe/unstable angina, occurred 6 months before treatment. ultrasonic Left ventricular ejection fraction \<50% was detected by cardiogram, indicating poor arrhythmia control.
- High blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg).
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Known or suspected allergy to the investigational drug or a similar drug.
- Active or uncontrolled severe infection.
- Known human immunodeficiency virus (HIV) infection.
- Any other disease with clinically significant metabolic abnormalities, physical abnormalities, or laboratory abnormalities Often, in the investigator's judgment, there is reason to suspect that the patient has a disease or condition that is not suitable for use of the investigational drug state (such as having a seizure and requiring treatment) that will either affect the interpretation of the study results or make the patient In a high-risk situation.
- Patients who have been co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing
- Inability to comply with study protocols or study procedures.
- Patients who are not suitable to participate in this trial judged by the investigator.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06894797
Start Date
April 1 2025
End Date
October 31 2027
Last Update
March 25 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, China