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New chemo cocktail aims to outperform standard care in colorectal cancer

NCT ID NCT07309289

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a new combination of chemotherapy drugs (NALIRIFOX) plus targeted therapy works better than the standard FOLFOX regimen for people with metastatic colorectal cancer that has not been treated before. About 144 participants will receive one of the two treatments. The study aims to see if the new combo can delay cancer growth and improve response rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Irinotecan liposome, oxaliplatin, 5-FU, leucovorin, bevacizumab, cetuximab
What this could lead to
If successful, this could provide a more effective first-line treatment option for people with metastatic colorectal cancer, potentially improving survival and tumor shrinkage.
What could go wrong
This is a Phase 3 trial, but results may not show a significant benefit over standard therapy. Side effects from the combination chemotherapy and targeted drugs can be severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥18 years old * Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma * The unresectable stage of metastatic disease has not received any systemic antitumor therapy * For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 12 months removed from the date of last administration of neoadjuvant or adjuvant therapy * The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria * ECOG 0\~1 * Normal bone marrow and organ function * Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form Exclusion Criteria: * Patients with known MSI-H or dMMR who were evaluated by investigators as suitable for treatment with immune checkpoint inhibitors. * Patients allergic to the investigational drug and its excipients * Underweight (body mass index \[BMI\]\<18.5 kg/m\^2 * Known or suspected central nervous system metastasis * Received irinotecan before enrollment * Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment * Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 class I or below. * The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment * Serious gastrointestinal disorders * Interstitial lung disease * Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding) * Patients with fluid accumulation that couldn't reach a stable state and small amount of pleural effusion or ascites on imaging without clinical symptoms could be enrolled * Intestinal obstruction, or a risk of intestinal obstruction in the short term * Gastrointestinal perforation, intraperitoneal abscess, and fistula * Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc * Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer * Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding * The researchers didn't consider it appropriate to participate in this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Zhongshan Hospital

    RECRUITING

    Shanghai, China

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