Neoadjuvant Therapy （NALIRIFOX） for Locally Advanced Colon and Upper Rectal Cancer

NCT07020468 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: CancerShantouUMC
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluating the efficacy and safety of Oxaliplatin + Irinotecan Liposome + 5-FU/LV in patients with Locally Advanced Colorectal Cancer and Upper Rectal Cancer. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as advanced colon cancer and upper rectal cancer; 3. Clinical staging of T3N+ or T4Nany with initially resectable tumors; 4. No distant metastasis observed in routine chest and abdominal CT scans. The main question it aims to answer is Major Pathological Response Rate, referring to the proportion of patients who experience a significant reduction in the size of their tumor or near-complete pathological regression after treatment, typically assessed through a biopsy or surgical resection. Participants will be Chemotherapy administered before surgery, with 3-6 cycles of treatment, using the chemotherapy regimen of Oxaliplatin + Irinotecan Liposome + 5-FU/LV.

Conditions

Colorectal Cancer (CRC)

Keywords

Irinotecan Liposome; Locally Advanced Colorectal Cancer and Upper Rectal Cancer.; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Major pathological response rate

  24 months

Secondary Outcomes (1)

• Pathological complete response rate

  24 months

Other Outcomes (4)

• R0 resection rate

  24months

• objective response rate

  24 months

• disease-free survival

  24 months

Study Arms (1)

Oxaliplatin + Irinotecan Liposome + 5-FU/LV

EXPERIMENTAL

Drug: NALIRIFOX

Interventions

NALIRIFOX DRUG

The patients with Locally Advanced Colorectal Cancer and Upper Rectal Cancer will undergo neoadjuvant treatment with irinotecan liposome combined with oxaliplatin + 5-FU/LV (NALIRIFOX), with each treatment cycle lasting 2 weeks, for a total of 3-6 cycles.

Oxaliplatin + Irinotecan Liposome + 5-FU/LV

Eligibility Criteria

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

You may qualify if:

• Aged 18-75 years, both male and female are eligible;
• ECOG score of 0-1;
• Biopsy-confirmed pathological diagnosis of advanced-stage colon cancer or upper rectal cancer;
• Clinical staging of T3N+ or T4Nany with initially resectable disease;
• Routine chest and abdominal CT scans show no distant metastases;
• Bone marrow function: neutrophils (ANC) ≥1.5×10\^9/L, platelets (PLT) ≥100×10\^9/L, hemoglobin (Hb) ≥70g/L;
• Liver function: ALT, AST ≤2.5×ULN (upper limit of normal); total bilirubin ≤1.5×ULN; serum albumin ≥3 g/dL;
• Kidney function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated using Cockcroft-Gault formula);
• For female patients and those with reproductive potential, a negative pregnancy test must be conducted ≤72 hours prior to starting the study treatment, and they must agree to avoid pregnancy during the study treatment and for 6 months after the study treatment. For male patients with reproductive potential partners, they must agree to use adequate, medically approved contraception during the last study treatment and for 90 days afterward;
• Must be willing to undergo the neoadjuvant chemotherapy regimen in this study and sign an informed consent form.

You may not qualify if:

• Patients who have had other malignant tumors within the past 5 years (except for cured and non-recurring carcinoma in situ, basal cell carcinoma of the skin, etc.);
• Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined as persistent signs/symptoms related to infection that do not improve despite appropriate antibiotics, antiviral therapy, and/or other treatments;
• Patients with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmias, history of severe pericardial disease, and other cardiovascular diseases; uncontrolled hypertension (defined as a systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite standardized antihypertensive treatment), or a history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes (fasting blood glucose ≥10 mmol/L);
• Patients who are known to be allergic or intolerant to the investigational drug or its excipients in this study;
• Any clinical indicators showing contraindications for chemotherapy and surgery;
• Patients using strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1, etc.;
• Pregnant or breastfeeding women, and women of childbearing potential who refuse to use appropriate contraception during the trial;
• Patients who have participated in other clinical trials within 4 weeks prior to enrollment;
• Patients deemed unsuitable for participation in this study by the investigator.

Sponsors & Collaborators

• Affiliated Cancer Hospital of Shantou University Medical College: lead

Study Sites (1)

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515000, China

Location

Related Publications (3)

• Wong SJ, Moughan J, Meropol NJ, Anne PR, Kachnic LA, Rashid A, Watson JC, Mitchell EP, Pollock J, Lee RJ, Haddock M, Erickson BA, Willett CG. Efficacy endpoints of radiation therapy group protocol 0247: a randomized, phase 2 study of neoadjuvant radiation therapy plus concurrent capecitabine and irinotecan or capecitabine and oxaliplatin for patients with locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2015 Jan 1;91(1):116-23. doi: 10.1016/j.ijrobp.2014.09.031. Epub 2014 Nov 5.

  PMID: 25446610 BACKGROUND

• Fernandez-Martos C, Brown G, Estevan R, Salud A, Montagut C, Maurel J, Safont MJ, Aparicio J, Feliu J, Vera R, Alonso V, Gallego J, Martin M, Pera M, Sierra E, Serra J, Delgado S, Roig JV, Santos J, Pericay C. Preoperative chemotherapy in patients with intermediate-risk rectal adenocarcinoma selected by high-resolution magnetic resonance imaging: the GEMCAD 0801 Phase II Multicenter Trial. Oncologist. 2014 Oct;19(10):1042-3. doi: 10.1634/theoncologist.2014-0233. Epub 2014 Sep 10.

  PMID: 25209376 BACKGROUND

• Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.

  PMID: 33862000 BACKGROUND

Related Links

• The study protocol has not been registered on other websites. The detailed protocol will be available for viewing on this website once the clinical trial registration is approved.

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Muming Xv

  Affiliated Cancer Hospital of Shantou University Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: May 15, 2025
• Primary Completion: July 30, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)