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
Study ID
NCT07381777
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Locally Advanced Rectal Cancer (LARC)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • XELOX (Capecitabine and Oxaliplatin) — DRUG
    Capecitabine 1000mg/m2 BID + Oxaliplatin 130mg/m2 Q3W
  • Dostarlimab — DRUG
    Dostarlimab IV 500mg Q3W

Study Details

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 Dates

Start date
Jan 31, 2026
Status verified
May 2025
Primary completion
Jul 1, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: XELOX + DOSTARLIMAB (Arm A)
    4 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)
  • Active Comparator: XELOX (Arm B)
    4 cycle- XELOX alone as consolidation treatment

Primary Outcome Measure

Clinical complete response (cCR) at 12 months [ Time Frame: After 12 months of the end of the consolidation therapy ]

Central Contacts

Related Studies