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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05116085
- Acronym / sponsor ID
- BGB-A317-214
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab | Experimental | Drug: TislelizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: BGB-A317, TEVIMBRA®200 milligrams (mg) administered through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles | Drug | Tislelizumab |
Primary outcome
Major Pathological Response (MPR) Rate
Time frame: Approximately 10 weeks after first dose of study treatment
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.
4 secondary outcomes
Pathological Complete Response (pCR) Rate
Time frame: Approximately 10 weeks after first dose of study treatment
Event Free Survival (EFS)
Time frame: 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)
Time frame: 24 months and 36 months after first dose
Number of Participants Experiencing Adverse Events
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Colorectal Cancer, run by BeiGene at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) Rate (time frame: Approximately 10 weeks after first dose of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.