Colorectal CancerPhase 2NCT05116085
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer
A Phase 2 study testing Tislelizumab in people with Colorectal Cancer, run by BeiGene at 8 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 8 sitesChina
- Study dates
- 26 Jan 2022to 3 Jan 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Shandong Cancer Hospital
Jinan, Shandong, 250117
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, 266000
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Hubei Cancer Hospital
Wuhan, Hubei, 430079
About this study
Official title: 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
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.
Read the 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
- Being tested
- Tislelizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317, TEVIMBRA®
200 milligrams (mg) administered through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 10 weeks after first dose of study treatment
Secondary outcomes (4)
Pathological Complete Response (pCR) Rate
Defined as the percentage of participants with a complete absence of residual tumor (no remaining cancer cells) in the surgically resected primary tumor and in all resected lymph nodes after completing neoadjuvant therapy.
Measured: Approximately 10 weeks after first dose of study treatment
Event Free Survival (EFS)
Defined as the time from the first dose of study treatment until the first occurrence of any of the following events:
- Disease progression that prevents complete surgical remover of the tumor
- Local or distant recurrence after surgery
- Death from any cause
The median and other quartiles of EFS were estimated using the Kaplan-Meier Method.
Measured: 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)
The 2-year and 3-year EFS rates are defined as the percentage of participants without any EFS events at 24 months and 36 months after the first dose. EFS rates were estimated by the Kaplan-Meier method with 95% CI estimated using Greenwood's formula.
Measured: 24 months and 36 months after first dose
Number of Participants Experiencing Adverse Events
The incidence of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and immune-mediated adverse events (imAEs), was assessed for all participants who received at least one dose of study treatment. SAEs were defined as events that resulted in death, were life-threatening, required or prolonged hospitalization, caused significant disability, or were considered important medical events. imAEs were defined as adverse events consistent with immune-related mechanisms, such as autoimmune-like toxicities requiring clinical evaluation or immunosuppressive management.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start26 Jan 2022
- Primary completion26 Sep 2023
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116085
- Sponsor's protocol ID
- BGB-A317-214
- Other IDs
- CTR20212779
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2021
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.