Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, and tolerability of neo-adjuvant treatment with tislelizumab in participants with early-stage (Stage II-III) Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

Inclusion Criteria:

1. ECOG Performance status of 0 or 1.

2. Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III CRC with MSI-H confirmed by sponsor designated central laboratory. Participants should be eligible for an R0 resection with curative intent.

3. Evaluable or measurable disease as assessed by the investigator per RECIST v1.1.

4. Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 14 days before first dose.

Exclusion Criteria:

1. Any prior therapy for current CRC, including chemotherapy or radiotherapy or immunotherapy.

2. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.

3. Active autoimmune diseases or history of autoimmune diseases that may relapse.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.