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New drug combo may help avoid surgery in rectal cancer patients

NCT ID NCT07381777

Disease control Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the immunotherapy drug dostarlimab to standard chemotherapy (XELOX) after chemoradiation improves outcomes for people with locally advanced rectal cancer. About 270 participants will be randomly assigned to receive either the combination or chemotherapy alone. Those who have a complete response may choose to skip surgery and be monitored instead.

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 270 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Histologically proven rectal adenocarcinoma with distal extension less 16 cm from the anal verge. * Stage cT3-4 cN0 cM0, any cT cN+ M0 \[N+ stage, three or more lymph nodes of diameter \>0.5 cm measured by endorectal ultrasound, or one or more lymph nodes of diameter \>1 cm measured by magnetic resonance (MRI)\]. * Proficient mismatch repair (pMMR)/microsatellite stable status (MSS) or microsatellite instability (MSI)-low (MSI-L) * ECOG-Performance Status 0-1 * No previous treatment with chemotherapy or radiation therapy. * No prior exposure to immune-mediated therapy, excluding therapeutic anticancer vaccines. * Neutrophil count \>1,500/mL, platelet count \>100.000/mL, hemoglobin \>9.0 g/dL, serum creatinine \<1.5 3 upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase 2.5 3 ULN, total bilirubin \<1.5 3 ULN. * Signed written informed consent. Exclusion Criteria: * Subjects with active, known, or suspected autoimmune disease requiring systemic treatment (systemic steroids or immunosuppressive agents), except for subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune conditions only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Distant metastases documented. * Participants have received a live vaccine within 30 days of the planned start of study therapy. COVID-19 vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered non-live. * Participants have a current active history of pneumonitis or interstitial lung disease.

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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 (LARC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 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

  • A.O. Oncologia S. Croce e Carle - presidio Ospedaliero A. Carle

    Cuneo, Italy

  • AOU di Modena - Policlinico di Modena - DH Oncologico

    Modena, Italy

  • AOUC Azienda Ospedaliero - Universitaria Careggi Oncologia Medica

    Florence, Italy

  • ASST Brianza

    Vimercate, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, Italy

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola (FC), Italy

  • IRCCS Istituto clinico humanitas

    Rozzano, Italy

  • Oncologia Clinica Sperimentale Addome Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale

    Naples, Italy

  • Oncologia Falck - ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Oncologia Medica - Policlinico Universitario Gemelli IRCCS

    Roma, Italy

  • Oncologia Medica 1, A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette

    Torino, Italy

  • Oncologia Medica 2 Universitaria

    Pisa, Italy

  • Oncologia Medica Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, Italy

  • Oncologia Ricerca Clinica - IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Italy

  • Oncologia medica e prevenzione oncologica - Centro di Riferimento Oncologico

    Aviano, Italy

  • Ospedale San Donato - UOC Oncologia Medica dell'Aretino, Casentino, Valtiberina, Valdichiana Aretina

    Arezzo, Italy

  • S.C. Oncologia Medica, Ospedale Felettino

    La Spezia, Italy

  • SC Oncologia, Fondazione IRCCS Policlinico S. Matteo

    Pavia, Italy

  • SOC Oncologia Azienda sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia

    Udine, Italy

  • SOC di Oncologia Provinciale, AUSL IRCCS di Reggio Emilia

    Reggio Emilia, Italy

  • Struttura Complessa Oncologia Medica 1 - Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • U.O. C. di Oncologia Medica - OSPEDALE CIVILE SS ANNUNZIATA

    Sassari, Italy

  • U.O. Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino

    Genova, Italy

  • UOC Di Oncologia Medica AOU Federico II

    Naples, Italy

  • UOC Oncoematologia AOU Vanvitelli

    Naples, Italy

  • UOC Oncologia 1 - Ospedale Busonera - IRCCS Istituto Oncologico Veneto

    Padova, Italy

  • UOC Oncologia Medica - ARNAS Garibaldi PO Nesima

    Catania, Italy

  • UOC Oncologia Medica Azienda Ospedaliero Universitaria di Parma

    Parma, Italy

  • UOC Oncologia Medica IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Italy

  • UOC Oncologia Ravenna Dipartimento di Oncologia ed Ematologia - AUSL Romagna

    Ravenna, Italy

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