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New combo therapy aims to boost remission in tough rectal cancer

NCT ID NCT07527520

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a new approach for high-risk locally advanced rectal cancer. It combines a shorter course of radiation with chemotherapy (capecitabine and oxaliplatin) and an immunotherapy drug (serplulimab). The study will compare this combo to standard chemoradiation in 165 patients to see if it leads to higher complete remission rates.

What this could mean

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

Active substance
Moderately hypofractionated radiotherapy, capecitabine, oxaliplatin, and serplulimab
What this could lead to
If successful, this could offer a more effective and shorter treatment option for patients with high-risk locally advanced rectal cancer, potentially increasing the chance of complete remission.
What could go wrong
This is a phase 2 trial with only 165 participants, so results are preliminary. The combination of treatments may increase 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 165 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 2031

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 years and ≤ 75 years. * Histologically confirmed colorectal adenocarcinoma with the lower margin of the lesion ≤ 10 cm from the anal verge as assessed by MRI, and immunohistochemistry confirming pMMR, or genetic testing demonstrating MSI-L or MSS. * Presence of at least one of the following high-risk factors as assessed by pelvic MRI: cT4a/b; N2; extramural vascular invasion (EMVI+); mesorectal fascia involvement (MRF+); enlarged lateral lymph node (longest diameter \> 7 mm). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 * No prior surgery, radiotherapy, chemotherapy, or targeted therapy. * Able to tolerate radiotherapy, chemotherapy, and immunotherapy: ECOG performance status score 0-2. Laboratory results: white blood cell count ≥ 4.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 80 g/L, ALT \< 2 × ULN, total bilirubin \< 35 μmol/L, serum creatinine \< 1.5 × ULN or creatinine clearance ≥ 50 mL/min, thyroid-stimulating hormone within normal range (patients with stable thyroid function after hormone replacement therapy may be enrolled). * Willing to participate and able to provide written informed consent. Exclusion Criteria: * Presence of distant metastasis. * Patients with stage I or II rectal cancer who do not require preoperative neoadjuvant therapy. * Severe diseases involving the heart, lung, brain, kidney, gastrointestinal tract, or other systemic conditions. * Untreated chronic hepatitis B or HBV carriers with HBV DNA \> 500 IU/mL, or patients positive for HCV RNA. Patients with inactive hepatitis B surface antigen (HBsAg) carriers, those with hepatitis B who have been treated and are stable (HBV DNA \< 500 IU/mL), and those who have been cured of hepatitis C may be enrolled. * Active autoimmune disease or history of autoimmune disease with potential for relapse. * Receipt of corticosteroids (at a dose equivalent to prednisone \> 10 mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration. * History of thyroid dysfunction. * Severe chronic or active infection requiring systemic antifungal or antiviral therapy, including tuberculosis infection. * History of allergic constitution or allergy to multiple drugs. * History of prior pelvic radiotherapy. * History of inflammatory bowel disease. * Unwillingness to participate or inability to provide written informed consent.

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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

    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

  • Zhongshan hosptial, Fudan University

    Shanghai, 200032, China

More trials for these conditions

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