Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer.
NCT ID: NCT06894797
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2025-04-01
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy
Patients will receive Concurrent Chemoradiotherapy（Radiation + Capecitabine） followed by NALIRIFOX
Concurrent Chemoradiotherapy：5 Weeks in total
NALIRIFOX：8 Weeks in total
Concurrent Chemoradiotherapy（Radiation + Capecitabine）
Capecitabine 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
Irinotecan hydrochloride liposome injection (50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
Oxaliplatin
Oxaliplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
5-FU
5-FU (2400mg/m\^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.
Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy
Patients will receive NALIRIFOX followed by Concurrent Chemoradiotherapy（Radiation + Capecitabine）
Concurrent Chemoradiotherapy：5 Weeks in total
NALIRIFOX：8 Weeks in total
Concurrent Chemoradiotherapy（Radiation + Capecitabine）
Capecitabine 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
Irinotecan hydrochloride liposome injection (50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
Oxaliplatin
Oxaliplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
5-FU
5-FU (2400mg/m\^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.
Interventions
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Concurrent Chemoradiotherapy（Radiation + Capecitabine）
Capecitabine 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
Irinotecan hydrochloride liposome injection (50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
Oxaliplatin
Oxaliplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
5-FU
5-FU (2400mg/m\^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age: 18\~75 years old.
3. Histopathologically confirmed rectal adenocarcinoma.
4. Locally advanced rectal cancer, determined at baseline.
5. No prior systemic therapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
7. Expected survival ≥ 12 months.
8. 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
9. Microsatellite Stability (MSS) or proficient MisMatch Repair (pMMR).
Exclusion Criteria
2. microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
3. Distant metastasis
4. 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).
5. 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.
6. 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.
7. High blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg).
8. Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
9. Known or suspected allergy to the investigational drug or a similar drug.
10. Active or uncontrolled severe infection.
11. Known human immunodeficiency virus (HIV) infection.
12. 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.
13. 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
14. Inability to comply with study protocols or study procedures.
15. Patients who are not suitable to participate in this trial judged by the investigator.
18 Years
75 Years
ALL
No
Sponsors
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CSPC Ouyi Pharmaceutical Co., Ltd.
INDUSTRY
Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Yongheng Li
Director
Principal Investigators
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Yongheng Li, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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Central Contacts
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Xicheng Wang, MD
Role: CONTACT
Facility Contacts
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Xicheng Wang, MD
Role: backup
Other Identifiers
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CSPC-DNY- LARC-BJ01
Identifier Type: -
Identifier Source: org_study_id
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