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NCT05116085CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 13 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
33 (actual)
First submitted
20 Oct 2021
Start date
26 Jan 2022
Primary completion date
26 Sept 2023
Lead sponsor
BeiGene
NCT number
NCT05116085

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 33
  • From 26 Jan 2022 to the primary completion date, 26 Sept 2023
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants had received any prior treatment for their current colorectal cancer, including chemotherapy, radiotherapy, or immunotherapy.
  • Participants had any condition requiring systemic treatment with corticosteroids at doses greater than 10 milligrams (mg) of prednisone per day, or other immunosuppressive medications within 14 days before the first dose.

Other illness

  • Participants had active autoimmune diseases or a history of autoimmune diseases that could potentially relapse.
    • Note: Additional protocol-defined inclusion and exclusion criteria may have applied.

Who the study is looking for

  • Participants had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Participants had a pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III colon or rectal cancer (CRC) with microsatellite instability-high (MSI-H) status confirmed by a sponsor-designated central laboratory, or known MSI-H status confirmed by a local laboratory. Participants were required to be eligible for complete surgical removal of the tumor (R0 resection) with curative intent.
  • Participants had evaluable or measurable disease as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
  • Participants had adequate blood counts and organ function, as defined by protocol-specified laboratory test results obtained within 7 days before the first dose of study treatment.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Bengbu Medical College
Coordinator of this site? Confirm its status
BengbuChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Shandong Cancer Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
The Affiliated Hospital of Qingdao University Branch South
Coordinator of this site? Confirm its status
QingdaoChinaUnknown status
Liaoning Cancer Hospital and Institute
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Hubei Cancer Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.