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XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients
Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
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+) 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).
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2026-01-31
Completion Date
2030-12-31
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
XELOX (Capecitabine and Oxaliplatin)
Capecitabine 1000mg/m2 BID + Oxaliplatin 130mg/m2 Q3W
Dostarlimab
Dostarlimab IV 500mg Q3W
Locations (30)
Ospedale San Donato - UOC Oncologia Medica dell'Aretino, Casentino, Valtiberina, Valdichiana Aretina
Arezzo, Italy
Oncologia medica e prevenzione oncologica - Centro di Riferimento Oncologico
Aviano, Italy
UOC Oncologia Medica IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
Oncologia Medica Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
UOC Oncologia Medica - ARNAS Garibaldi PO Nesima
Catania, Italy
A.O. Oncologia S. Croce e Carle - presidio Ospedaliero A. Carle
Cuneo, Italy
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