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New cocktail aims to shrink rectal tumors before surgery

NCT ID NCT07150949

Disease control Sponsor: Fudan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase II trial tests whether adding an immunotherapy drug (serplulimab) and a COX-2 inhibitor (celecoxib) to standard chemoradiotherapy can improve outcomes for people with locally advanced rectal cancer. 138 participants will receive either long-course or short-course radiation plus chemotherapy, with the new drugs added. The main goal is to see how many patients have a complete response, meaning no cancer remains 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
Oxaliplatin, capecitabine, serplulimab (PD-1 antibody), and celecoxib (COX-2 inhibitor)
What this could lead to
If successful, this combination could increase the chance of eliminating the tumor before surgery, potentially allowing some patients to avoid surgery altogether.
What could go wrong
This is an early phase II trial with only 138 participants, so results may not apply to everyone. Adding immunotherapy and a COX-2 inhibitor may increase side effects like immune-related reactions.

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 138 people

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

Expected to start

Aug 2025

An estimate. Start dates often move.

Expected to finish

Aug 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: 1. Age 18-75 years, gender not limited 2. Pathologically confirmed rectal adenocarcinoma 3. ≤10 cm from the anus 4. Baseline stage T3-4/N+ 5. No distant metastasis 6. MSI/MMR status MSS/pMMR 7. Karnofsky performance status score ≥70 8. No prior chemotherapy or other anti-cancer treatment prior to enrollment 9. No prior immunotherapy prior to enrollment 10. Ability to comply with the study protocol 11. Written informed consent Exclusion Criteria: 1. Pregnancy or breast-feeding women; 2. Known history of other malignancies within 5 years; 3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc; 4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy); 5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction; 6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment; 7. Uncontrolled infection which needs systemic therapy; 8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents; 9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection 10. Allergic to any component of the therapy.

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Conditions

The condition(s) this trial relates to.

rectal cancer

As listed by the trial registrant

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

Locally advanced rectal cancer Neoadjuvant therapy

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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

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