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Colorectal Cancer (CRC)Phase 4HOPENCT07020468

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

A Phase 4 study testing NALIRIFOX in people with Colorectal Cancer (CRC), run by Affiliated Cancer Hospital of Shantou University Medical College at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer (CRC)
What is being tested?
NALIRIFOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteChina
Study dates
15 May 2025to 31 May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515000

Other trials in China

About this study

Official title: A Clinical Study on the Efficacy and Safety of Oxaliplatin + Irinotecan Liposome + 5-FU/LV as Neoadjuvant Therapy for Locally Advanced Colon and Upper Rectal Cancer

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.

Read the detailed description

This study is a single-center, single-arm, prospective clinical trial. A total of 57 patients are expected to be enrolled over 24 months, with a 1-year follow-up observation period. Eligible participants who meet the inclusion criteria and do not meet the exclusion criteria will receive neoadjuvant treatment with irinotecan liposome combined with oxaliplatin + 5-FU/LV (NALIRIFOX). Treatment will be administered in 2-week cycles for 3-6 cycles, and surgery will be planned for those who meet surgical criteria. For those who do not meet surgical criteria, the subsequent treatment plan will be decided by the investigator. Postoperative adjuvant therapy will be determined by the investigator based on the patient's condition. The primary endpoint is the major pathological response (MPR) rate, and secondary endpoints include pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), disease-free survival (DFS), and safety.

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.

Being tested
NALIRIFOX
Keywords
Irinotecan Liposome, Locally Advanced Colorectal Cancer and Upper Rectal Cancer., Neoadjuvant chemotherapy
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NALIRIFOXDrug

    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.

Study groups in NCT07020468
Study groupRoleWhat they receive
Oxaliplatin + Irinotecan Liposome + 5-FU/LVExperimentalNot described
Receives: Drug: NALIRIFOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major pathological response rate

    Measured: 24 months

Secondary outcomes (1)

  1. Pathological complete response rate

    The Pathological Complete Response Rate (pCR) is typically expressed as a percentage (%). It refers to the proportion of patients in whom no cancer cells are detected in the tumor tissue after treatment, as assessed by pathological evaluation, indicating a complete response.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start15 May 2025
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07020468
Sponsor's protocol ID
CancerShantouUMC
Acronym
HOPE
Status last verified
May 2025
First submitted
27 May 2025
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25446610

  • 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.

    PubMed 25209376

  • 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.

    PubMed 33862000

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NALIRIFOX in people with Colorectal Cancer (CRC), run by Affiliated Cancer Hospital of Shantou University Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological response rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07020468, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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