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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Tislelizumab

• Registration Number: NCT05116085
• Lead Sponsor: BeiGene

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-10
• Study Start: 2022-01-26
• Primary Completion: 2023-09-26
• Study Completion: 2025-01-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. ECOG Performance status of 0 or 1.
2. Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III Colon/Rectal Cancer (CRC) with MSI-H confirmed by sponsor designated central laboratory or known MSI-H status by local 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 7 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab	Tislelizumab	Tislelizumab administered intravenously before surgery during the neo-adjuvant phase

Primary Outcome Measures

Name	Time	Method
Major pathological response (MPR) rate	approximately 16 months	MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor

Secondary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	approximately 50 months	Time from first dose until disease progression
2-year/3-year EFS rate	approximately 50 months	Percentage of participants free from EFS events at 2 years and 3 years estimated using the Kaplan-Meier method.
Pathological complete response (pCR) rate	approximately 16 months	Percentage of participants with absence of residual tumor
Proportion of participants expressing Potential Biomarkers in Blood	approximately 50 months	Potential biomarkers include immune cell infiltration, PD-L1 expression, tumor mutational burden (TMB) and DNA mutation, gene expression profile (GEP)
Number of Participants With Clinically Significant Vital Signs	approximately 16 months	Vital signs include pulse rate and blood pressure
Number of Participants With Clinically Significant Laboratory Values	approximately 16 months	Laboratory parameters include hematology , chemistry, coagulation and urinalysis
Number of Participants With Clinically Significant Physical Examination Findings	approximately 16 months	A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	approximately 16 months	Number of participants with one or more TEAE, including serious adverse events and immune-mediated adverse events, graded according to NCI-CTCAE Version 5.0.

Trial Locations

Locations (8)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

The Affiliated Hospital of Qingdao University Branch South; 🇨🇳 Qingdao, Shandong, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China

Sun Yat Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

Liaoning Cancer Hospital and Institute; 🇨🇳 Shenyang, Liaoning, China

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China