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New drug cocktail aims to shrink colon tumors before surgery

NCT ID NCT07156682

Disease control Sponsor: Qilu Hospital of Shandong 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether a combination of two immunotherapy drugs (iparomlimab and tuvonralimab) plus chemotherapy can shrink tumors before surgery in people with stage III colon cancer that is microsatellite stable (pMMR/MSS). About 21 participants will receive four cycles of the drug combo, then undergo surgery. The main goal is to see if the cancer disappears completely after treatment.

What this could mean

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

Active substance
iparomlimab and tuvonralimab (QL1706) plus XELOX chemotherapy (oxaliplatin and capecitabine)
What this could lead to
If this works, it could lead to a new treatment option that shrinks tumors before surgery, potentially improving outcomes for people with hard-to-treat stage III colon cancer.
What could go wrong
This is a small, early-phase study with only 21 participants, so results may not apply to everyone. The combination therapy may cause significant side effects, and it is not yet known if it will improve long-term survival.

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 21 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jun 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 between 18 and 75 years. * Histologically or clinically confirmed initially resectable Stage III colon cancer according to the AJCC 8th edition. * ECOG performance status of 0 or 1. * pMMR/MSS status confirmed by a local testing center. * No planned neoadjuvant radiotherapy. * Participants must voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance. * Adequate organ function. Exclusion Criteria: * Stage IV colon cancer. * Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1. * Current participation in another clinical trial and receiving investigational drugs. * History of or contraindication to severe allergic reactions to immunotherapy. * Pregnancy or lactation. * Active infection requiring treatment. * Use of immunosuppressive medications. * Active cardiovascular disease, including stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure, or severe uncontrolled arrhythmia requiring medication that may preclude surgery. * Patients with acute conditions such as obstruction, hemorrhage, or perforation that require immediate surgery. * Any other condition deemed by the investigator to render the participant unsuitable for the clinical study.

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm

As listed by the trial registrant

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

Colon cancer MSS/PMMR QL1706

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

  • Qilu hospital of Shandong University

    Jinan, Shandong, 250012, China

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