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New chemo cocktail aims to slow advanced colon cancer

NCT ID NCT07621497

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new chemotherapy regimen called FOLFOX8 against the standard mFOLFOX6, both combined with targeted drugs (bevacizumab or cetuximab), as a first treatment for people with metastatic colorectal cancer that cannot be surgically removed. About 229 participants will be randomly assigned to one of the two regimens. The main goal is to see if FOLFOX8 delays cancer growth longer than the standard approach.

What this could mean

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

Active substance
FOLFOX8 (oxaliplatin, 5-fluorouracil, levofolinic acid) and mFOLFOX6 combined with bevacizumab or cetuximab
What this could lead to
If successful, this could lead to a more effective first-line chemotherapy regimen for people with advanced colorectal cancer that cannot be removed by surgery.
What could go wrong
This is an early Phase 2 trial with only 229 participants, so results may not apply to all patients. The new regimen may not improve survival and could have side effects like nerve damage or low blood counts.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 229 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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: 1. Age ≥ 18 years, male or female. 2. ECOG performance status 0-2. 3. Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no prior treatment for unresectable or metastatic disease. 4. Adequate organ function: Hb ≥ 70 g/L; WBC ≥ 3.0×10⁹/L; NEUT ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; AST and ALT ≤ 3× ULN; sCr ≤ 2× ULN; TBIL ≤ 2× ULN. 5. Expected survival \> 3 months. Exclusion Criteria: 1. Known allergy to the study drug(s) and/or their excipients. 2. Contraindications to chemotherapy. 3. Patients with MSI-H or dMMR colorectal cancer. 4. Patients with BRAF mutation. 5. Pregnant or breastfeeding women. 6. History of any second malignancy within 2 years prior to randomization, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, or breast carcinoma in situ, which are allowed for enrollment. 7. Patients with systemic medical or psychiatric disorders that make them unsuitable for chemotherapy. 8. Patients deemed unsuitable for enrollment in this study by the investigator's judgment. 9. Participation in another clinical trial of an investigational drug within 4 weeks prior to randomization.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Metastatic colorectal cancer (CRC)

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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.