NCT05116085

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

A Single-Arm, Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Early-Stage (Stage II-III) Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study was to help meet the medical needs of people in China with certain types of solid tumors that have specific genetic changes called microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR). The study looked at how well the drug tislelizumab works and how safe it is when given before surgery (neoadjuvant treatment) for these types of tumors.

Detailed description

This study enrolled participants with Stage II or III resectable colorectal cancer (CRC). Participants with unknown microsatellite instability (MSI) or mismatch repair (MMR) status provided blood and tumor tissue samples during a prescreening period (within 56 days before the first dose) for central laboratory confirmation of MSI status. Participants with known MSI-high (MSI-H) or deficient MMR (dMMR) status by local laboratory also underwent central confirmation when tumor samples were available. Eligible participants received tislelizumab 200 mg by intravenous infusion once every 3 weeks for 3 cycles as neoadjuvant therapy. After completion of neoadjuvant treatment, participants underwent complete surgical removal (R0 resection) of their tumor, and surgical specimens were assessed for pathological response, including major pathological response (MPR) and pathological complete response (pCR). Post-surgery, participants continued adjuvant therapy and follow-up as determined by their investigator.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 milligrams (mg) administered through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles

Timeline

• Start date: 2022-01-26
• Primary completion: 2023-09-26
• Completion: 2025-01-03
• First posted: 2021-11-10
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

8 sites across 1 country: China