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Immunotherapy combo shows promise in colorectal cancer fight

NCT ID NCT06154538

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding an immune checkpoint inhibitor (a type of immunotherapy) to standard chemotherapy before surgery can improve outcomes for people with locally advanced colorectal cancer. About 170 participants will be randomly assigned to receive either the combination or chemotherapy alone. The main goal is to see if the combination leads to a higher rate of complete cancer disappearance in the removed tissue.

What this could mean

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

Active substance
immune checkpoint inhibitor (PD-1 antibody) plus FOLFOX chemotherapy
What this could lead to
If it works, this could lead to a more effective pre-surgery treatment that increases the chance of eliminating all cancer cells before surgery.
What could go wrong
This is an early phase 2 trial with only 170 participants, so results may not apply to everyone. Adding immunotherapy to chemo can also increase side effects like immune-related inflammation.

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 170 people

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

Started

Nov 2023

Expected to finish

Nov 2028

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 to 75 years

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: * Age 18 to 75, no gender restrictions; * Histologically or cytologically confirmed colorectal adenocarcinoma; * Clinically diagnosed as stage II/III colorectal cancer based on CT and/or MRI (according to the 8th edition of AJCC staging); * Sufficient tumor tissue specimens for mismatch repair protein expression or microsatellite instability testing; * No prior systemic drug therapy and/or radiotherapy for colorectal adenocarcinoma; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Normal major organ function, no severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency diseases (see protocol for details); * Voluntary participation in this study and signed informed consent form; * Expected good compliance to complete the study treatment, follow-up for efficacy and adverse reactions according to the protocol requirements. Exclusion Criteria: * Pathology is other malignant tumors besides adenocarcinoma, such as squamous cell carcinoma, gastrointestinal stromal tumor, melanoma, etc.; * Within 5 years prior to the first use of investigational drug, diagnosed with other malignant tumors, excluding effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ cervical cancer and/or breast cancer effectively removed; * Any distant metastatic colorectal adenocarcinoma (according to AJCC 8th edition staging, determined as M1), including but not limited to distant lymph node metastasis, liver metastasis, lung metastasis, intraperitoneal dissemination, or malignant peritoneal effusion; * Various severe underlying diseases and autoimmune diseases (see protocol for details); * Unable to control recurrent bleeding or subjects who received blood transfusion within 2 weeks prior to the first use of investigational drug; * Any other circumstances where the investigator believes it may increase the risk associated with participating in the study, the administration of the investigational drug, or affect the subject's ability to receive the investigational drug and the reliability of the study results.

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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

    3 sites. 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

  • Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100038, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250000, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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