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Locally Advanced Rectal Cancer (LARC)Phase 2IMMUNOSTARNCT07381777

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

A Phase 2 study testing XELOX (Capecitabine and Oxaliplatin) and Dostarlimab in people with Locally Advanced Rectal Cancer (LARC), run by Gruppo Oncologico Italiano di Ricerca Clinica at 30 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

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+)… Read more about this study

Who is it for?
Any age
Conditions the study is for
Locally Advanced Rectal Cancer (LARC)
What is being tested?
XELOX (Capecitabine and Oxaliplatin) and Dostarlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
30 sitesItaly
Study dates
31 Jan 2026to 31 Dec 2030
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carmine Pinto, MD contact

+39 0522 96212

Carmine.Pinto@ausl.re.it

30 sites in 1 country

Italy30 sites

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

    Arezzo

    Carlo Milandri, +39 0575 255438, carlo.milandri@uslsudest.toscana.it

    Carlo Milandri

  • Oncologia medica e prevenzione oncologica - Centro di Riferimento Oncologico

    Aviano

    Michela Guardascione, +39 0434 659024, michela.guardascione@cro.it

    Michela Guardascione

  • UOC Oncologia Medica IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna

    Fabiola Lorena Rojas, +39 051 6361259, fabiolalorena.rojas@aosp.bo.it

    Fabiola Lorena Rojas

  • Oncologia Medica Fondazione Poliambulanza Istituto Ospedaliero

    Brescia

    Michela Lambertini, +39 030 3515557, michela.libertini@poliambulanza.it

    Michela Lambertini

  • UOC Oncologia Medica - ARNAS Garibaldi PO Nesima

    Catania

    Roberto Bordonaro, +39 095 7595936, rbordonaro63@gmail.com

    Roberto Bordonaro

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

    Cuneo

    Elena Fea, +39 0171 616350, fea.e@ospedale.cuneo.it

    Elena Fea

  • AOUC Azienda Ospedaliero - Universitaria Careggi Oncologia Medica

    Florence

    Lorenzo Antonuzzo, +39 055 794 7908, lorenzo.antonuzzo@gmail.com

    Lorenzo Antonuzzo

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

    Genova

    Alessandro Pastorino, +39 010 555 3301, alessandro.pastorino@hsanmartino.it

    Alessandro Pastorino

  • S.C. Oncologia Medica, Ospedale Felettino

    La Spezia

    Carlo Aschele, +39 018 7533688, carlo.aschele@asl5.liguria.it

    Carlo Aschele

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

    Meldola (FC)

    Francesco Giulio Sullo, +39 0543 739 100, francesco.sullo@irst.emr.it

    Francesco Giulio Sullo

  • Oncologia Falck - ASST Grande Ospedale Metropolitano Niguarda

    Milan

    Salvatore Siena, +39 02 6444.2291, salvatore.siena@ospedaleniguarda.it

    Salvatore Siena

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

    Milan

    Filippo Pietrantonio, +39 02 23903807, filippo.pietrantonio@istitutotumori.mi.it

    Filippo Pietrantonio

  • AOU di Modena - Policlinico di Modena - DH Oncologico

    Modena

    Fabio Gelsomino, +39 059 422 4982, gelsomino.fabio@aou.mo.it

    Fabio Gelsomino

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

    Naples

    Antonio Avallone, +39 0815 903629, a.avallone@istitutotumori.na.it

    Antonio Avallone

  • UOC Di Oncologia Medica AOU Federico II

    Naples

    Chiara Carlomagno, +39 081 7464271, chiara.carlomagno@unina.it

    Chiara Carlomagno

  • UOC Oncoematologia AOU Vanvitelli

    Naples

    Erika Martinelli, +39 081 566 4377, erika.martinelli@unicampania.it

    Erika Martinelli

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

    Padova

    Francesca Bergamo, +39 049 8215953, francesca.bergamo@iov.veneto.it

    Francesca Bergamo

  • UOC Oncologia Medica Azienda Ospedaliero Universitaria di Parma

    Parma

    Francesca Pucci, +39 0521 702316, fpucci@ao.pr.it

    Francesca Pucci

  • SC Oncologia, Fondazione IRCCS Policlinico S. Matteo

    Pavia

    Anna Pagani, +39 0382 503 689, a.pagani@smatteo.pv.it

    Anna Pagani

  • Oncologia Medica 2 Universitaria

    Pisa

    Gianluca Masi, +39 050 992463, Gianluca.masi@unipi.it

    Gianluca Masi

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

    Ravenna

    Stefano Tamberi, +39 0544 285206, stefano.tamberi@auslromagna.it

    Stefano Tamberi

  • SOC di Oncologia Provinciale, AUSL IRCCS di Reggio Emilia

    Reggio Emilia

    Maria Banzi, +39 0522 296756, banzi.maria@ausl.re.it

    Maria Banzi

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma

    Giuseppe Tonini, +39 06 2254 112 01, g.tonini@policlinicocampus.it

    Giuseppe Tonini

  • Oncologia Medica - Policlinico Universitario Gemelli IRCCS

    Roma

    Giampaolo Tortora, +39 06 3015 4953, lisa.salvatore@policlinicogemelli.it

    Lisa Salvatore

  • IRCCS Istituto clinico humanitas

    Rozzano

    Alberto Puccini, +39 348-9350612, alberto.puccini@hunimed.eu

    Alberto Puccini

  • Oncologia Ricerca Clinica - IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo

    Tiziana Latiano, +39 088 2410640, t.latiano@operapadrepio.it

    Tiziana Latiano

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

    Sassari

    Alessio Cogoni, +39 0792 644622, Alessio.cogoni@aouss.it

    Alessio Cogoni

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

    Torino

    Massimo Di Maio, +39 011 633 5580, massimo.dimaio@unito.it

    Massimo Di Maio

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

    Udine

    Valentina Fanotto, +39 0432 554586, valentina.fanotto@asufc.sanita.fvg.it

    Valentina Fanotto

  • ASST Brianza

    Vimercate

    Salvatore Artale, +39 039 665 7115, salvatore.artale@asst-brianza.it

    Salvatore Artale

Other trials in Italy

About this study

Official title: Phase II Randomized Trial of XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients - IMMUNOSTAR Trial GOIRC-02-2024

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).

Read the detailed description

This is a phase II, multicenter, randomized (2:1) controlled, clinical trial to evaluate the preliminary efficacy and safety of consolidation chemotherapy (XELOX) plus anti-PD-1 antibody (dostarlimab) after standard long-course CRT followed by adjuvant dostarlimab versus follow-up (ARM A) compared to XELOX alone as consolidation (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.

Subsequent randomization into a ratio 1:1 will be performed after surgery, only for patients randomized in ARM A, to receive adjuvant dostarlimab for a maximum of 8 cycles (ARM A1) versus only follow-up (ARM A2), and in ARM B only follow-up (Figure 1).

If clinical complete responses (cCR) are documented after restaging, the patient may choose not to proceed with surgery and pursue nonoperative management (NOM) (Figure 1).

The patients before randomization will be stratified as follows:

  • cT4 or < cT4 stage;
  • positive or negative lymph nodes.
Being tested
XELOX (Capecitabine and Oxaliplatin), Dostarlimab
Keywords
Consolidation chemotherapy, dostarlimab, pMMR/MSS, MSI-Low, LARC, phase II, clinical complete response (cCR), safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XELOX (Capecitabine and Oxaliplatin)Drug

    Capecitabine 1000mg/m2 BID + Oxaliplatin 130mg/m2 Q3W

  • DostarlimabDrug

    Dostarlimab IV 500mg Q3W

Study groups in NCT07381777
Study groupRoleWhat they receive
XELOX + DOSTARLIMAB (Arm A)Experimental4 cycle - consolidation chemotherapy (XELOX) plus anti-PD-1 antibody (dostarlimab) after standard long-course CRT, followed by randomisation to adjuvant dostarlimab (Arm A1) versus follow-up (Arm A2)
Receives: Drug: XELOX (Capecitabine and Oxaliplatin); Drug: Dostarlimab
XELOX (Arm B)Active comparator4 cycle- XELOX alone as consolidation treatment
Receives: Drug: XELOX (Capecitabine and Oxaliplatin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical complete response (cCR) at 12 months

    To evaluate the clinical complete response (cCR) after 12 months of the end of consolidation treatment, defined as an absence of residual disease on digital and endoscopic rectal examination, as well as the absence of residual disease on rectal MRI, with no restricted diffusion on T2-weighted imaging (cT0N0M0), or the pathological complete response (pCR), in patients who undergo surgery, defined as an absence of viable tumor cells after full pathologic examination of the resected specimen (pT0N0M0)

    Measured: After 12 months of the end of the consolidation therapy

Secondary outcomes (8)

  1. Clinical complete response (cCR) at 24 and 36 months

    To evaluate cCR at 24 and 36 months defined as an absence of residual disease on digital and endoscopic rectal examination, as well as the absence of residual disease on rectal MRI, with no restricted diffusion on T2-weighted imaging

    Measured: After 24 and 36 months of the end of the consolidation therapy

  2. Assessment of Organ Preservation Rate

    To assess Organ Preservation Rate defined as not undergoing Total Mesorectal Excision (TME), either as primary management or for local recurrence, or who did not have a permanent colostomy created, at any time up to 3 years.

    Measured: From the enrollmentat to any time up to 3 years

  3. Disease Free Survival

    To evaluate DFS

    Measured: From randomization to recurrence of a tumor up to 3 years

  4. Overall Survival

    To evaluate OS

    Measured: From initiation of study treatment to death from any cause up to 3 years

  5. Pathological Downstaging Rate

    Pathological downstaging defined as a reduction in tumor stage comparing post-surgical pathological TNM stage (ypTNM) with baseline clinical TNM stage (cTNM).

    Measured: Perioperative period (at surgical resection).

  6. Improvement of Quality of Life

    To assess the QoL measured as pre-defined PRO endpoints in this study are mean changes from baseline in the EORTC-QLQ-CR29 questionnaire administered at baseline, after chemoradiation, after consolidation therapy, before to start adjuvant therapy and at the end of adjuvant therapy

    Measured: Baseline, during treatment, and at the end of adjuvant therapy (approximately 12 months).

  7. Adverse Events

    To evaluate safety in terms of incidence, nature, frequency and severity of Adverse Events (AEs) and laboratory abnormalities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.

    Measured: From first dose of study treatment through study completion, an average of 3 years

  8. Association Between ctDNA Status and Clinical Outcomes

    ctDNA status (positive vs negative) assessed at predefined time points and its association with clinical outcomes, including disease recurrence and treatment decisions.

    Measured: From ctDNA assessment during treatment through follow-up, up to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start31 Jan 2026 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomization (2:1) to consolidation chemotherapy (XELOX) plus anti-PD-1 antibody (dostarlimab) after standard long-course CRT followed by adjuvant dostarlimab VS follow-up (ARM A) compared to XELOX alone as consolidation (ARM B) Arm A subsequent randomization (1:1) to adjuvant dostarlimab for a maximum of 8 cycles (ARM A1) VS only follow-up (ARM A2), and in ARM B only follow-up
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381777
Sponsor's protocol ID
GOIRC-02-2024
Acronym
IMMUNOSTAR
Status last verified
May 2025
First submitted
28 Mar 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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