XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients

Starting soon · Phase 2

Conditions studied: Locally Advanced Rectal Cancer (LARC)

In brief

This is a phase II, multicenter, randomized (2:1) controlled, clinical trial to evaluate the preliminary efficacy and safety of consolidation chemotherapy (XELOX) plus dostarlimab after standard long-course CRT (ARM A) compared to XELOX alone (ARM B) in patients with pMMR/MSS or MSI-Low LARC (cT3-4 cN0, any cT cN+) candidate to receive standard long course CRT followed by TME. After the surgery, the patients in ARM A will be randomized (1:1) to receive adjuvant dostarlimab (ARM A1) versus follow-up (ARM A2), and in ARM B only follow-up. If clinical complete responses (cCR) are documented after consolidation treatment, the patient may choose not to proceed with surgery and pursue nonoperative management (NOM).

Key facts

Study ID: NCT07381777
Run by: Gruppo Oncologico Italiano di Ricerca Clinica
People needed: 270
Starts: 2026-01-31
Expected to finish: 2030-12-31
Last updated by the study team: 2026-02-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

AOUC Azienda Ospedaliero - Universitaria Careggi Oncologia Medica — Florence, Italy
U.O. Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino — Genova, Italy
S.C. Oncologia Medica, Ospedale Felettino — La Spezia, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola (FC), Italy
Oncologia Falck - ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
Struttura Complessa Oncologia Medica 1 - Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
AOU di Modena - Policlinico di Modena - DH Oncologico — Modena, Italy
Oncologia Clinica Sperimentale Addome Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale — Naples, 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 Azienda Ospedaliero Universitaria di Parma — Parma, Italy
SC Oncologia, Fondazione IRCCS Policlinico S. Matteo — Pavia, Italy
Oncologia Medica 2 Universitaria — Pisa, Italy
UOC Oncologia Ravenna Dipartimento di Oncologia ed Ematologia - AUSL Romagna — Ravenna, Italy
SOC di Oncologia Provinciale, AUSL IRCCS di Reggio Emilia — Reggio Emilia, Italy
Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Italy
Oncologia Medica - Policlinico Universitario Gemelli IRCCS — Roma, Italy
IRCCS Istituto clinico humanitas — Rozzano, Italy
Oncologia Ricerca Clinica - IRCCS Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy
U.O. C. di Oncologia Medica - OSPEDALE CIVILE SS ANNUNZIATA — Sassari, Italy
Oncologia Medica 1, A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette — Torino, Italy
SOC Oncologia Azienda sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia — Udine, Italy
ASST Brianza — Vimercate, Italy
Ospedale San Donato - UOC Oncologia Medica dell'Aretino, Casentino, Valtiberina, Valdichiana Aretina — Arezzo, Italy

Full record on ClinicalTrials.gov

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