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Triple-Drug attack aims to shrink tough colorectal tumors before surgery

NCT ID NCT07365592

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether adding an immunotherapy drug (anti-PD-1) and a diabetes drug (sitagliptin) to standard chemotherapy can shrink tumors before surgery in people with locally advanced colorectal cancer that has a specific genetic profile (pMMR). About 138 adults aged 18–75 will receive the combination for two cycles before surgery. The goal is to see if the treatment is safe and helps reduce tumor size.

What this could mean

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

Active substance
chemotherapy (oxaliplatin and capecitabine) plus an anti-PD-1 antibody and sitagliptin
What this could lead to
If successful, this combination could shrink tumors before surgery in patients with a hard-to-treat form of colorectal cancer, potentially improving surgical outcomes and long-term control.
What could go wrong
This is an early-phase trial (Ib/II) with a small number of participants, so results may not apply broadly. Adding more drugs also raises the risk of side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 138 people

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

Started

Apr 2026

Expected to finish

Dec 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 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: * Pathologically diagnosed colorectal adenocarcinoma * Age ≥18 years old and ≤75 years old * MRI/CT stage T3-4aNany and TanyN1-2, without distant metastasis * Life expectancy of 1 year The above * Informed consent, no contraindications to chemotherapy exist * pMMR diagnosed by IHC Exclusion Criteria: * Refused to participate in this study * Multifocal colorectal cancer * Past history of malignant tumors, except for basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ * Unable to receive chemotherapy , such as but not limited to bone marrow suppression, etc * Major organ diseases (such as but not limited to COPD, coronary heart disease and renal insufficiency, etc.) acute attack and or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia and myocarditis, etc.), * ASA score\> 3 * Mental disorder or illiteracy or language and communication barriers cannot understand the research plan * Colorectal tumor has obstruction or high risk of obstruction and or there is bleeding and/or perforation * Peripheral sensory nerve disorder, unable to receive oxaliplatin chemotherapy * Lateral pelvic lymph node metastasis (mainly supplied by internal iliac artery) * Pregnancy or breastfeeding * Unable to accept MRI examination * Consecutive use of glucocorticoids for more than 3 days within 1 month before signing the consent form * Diabetes or impaired glucose tolerance who may require drug intervention * Other scenarios deemed inappropriate by the investigators

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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.

Colorectal cancer

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

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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