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

NCT05116085 | Completed Phase 2 Results

• 2 other identifiers: BGB-A317-214CTR20212779
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR) Rate

  MPR rate is defined as the percentage of participants whose resected primary tumor shows 10% or less remaining viable cancer cells after completing neoadjuvant therapy.

  Approximately 10 weeks after first dose of study treatment

Secondary Outcomes (4)

• Pathological Complete Response (pCR) Rate

  Approximately 10 weeks after first dose of study treatment

• Event Free Survival (EFS)

  From first dose to final analysis data cutoff (03JAN2025), disease progression, initiation of a new anticancer therapy, or death; whichever came first. Median follow-up was 21.7 months.

• 2-Year and 3-Year Event Free Survival (EFS)

  24 months and 36 months after first dose

• Number of Participants Experiencing Adverse Events

  From the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first (up to 03JAN2025). Maximum treatment duration was 2.3 months.

Study Arms (1)

Tislelizumab

EXPERIMENTAL

Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

200 milligrams (mg) administered through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles

Also known as: BGB-A317, TEVIMBRA®

Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants had active autoimmune diseases or a history of autoimmune diseases that could potentially relapse.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (8)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

The Affiliated Hospital of Qingdao University Branch South

Qingdao, Shandong, 266000, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 10, 2021
• Study Start: January 26, 2022
• Primary Completion: September 26, 2023
• Study Completion: January 3, 2025
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (8)