Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer.

NCT06894797 | Recruiting DMC

• 1 other identifier: CSPC-DNY- LARC-BJ01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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, Multicenter, Phase II Study.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  To evaluate the efficacy of anti-tumor

  From baseline up to approximately 3 months

Study Arms (2)

Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy

EXPERIMENTAL

Patients will receive Concurrent Chemoradiotherapy（Radiation + Capecitabine） followed by NALIRIFOX Concurrent Chemoradiotherapy：5 Weeks in total NALIRIFOX：8 Weeks in total

Radiation: Concurrent Chemoradiotherapy（Radiation + Capecitabine）; Drug: irinotecan hydrochloride liposome injection; Drug: Oxaliplatin; Drug: 5-FU

Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy

EXPERIMENTAL

Patients will receive NALIRIFOX followed by Concurrent Chemoradiotherapy（Radiation + Capecitabine） Concurrent Chemoradiotherapy：5 Weeks in total NALIRIFOX：8 Weeks in total

Radiation: Concurrent Chemoradiotherapy（Radiation + Capecitabine）; Drug: irinotecan hydrochloride liposome injection; Drug: Oxaliplatin; Drug: 5-FU

Interventions

Concurrent Chemoradiotherapy（Radiation + Capecitabine） RADIATION

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

Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy; Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy

irinotecan hydrochloride liposome injection DRUG

Irinotecan hydrochloride liposome injection (50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.

Also known as: Nal-IRI

Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy; Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy

Oxaliplatin DRUG

Oxaliplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.

Also known as: OXA

Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy; Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy

5-FU DRUG

5-FU (2400mg/m\^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.

Also known as: fluorouracil

Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy; Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; irinotecan sucrosofate; Oxaliplatin; Fluorouracil

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Yongheng Li, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongheng Li, MD

CONTACT

13810277398; yonghenglee@163.com

Xicheng Wang, MD

CONTACT

13439563949

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CN (1)