A Phase 2 interventional study of Tislelizumab in Colorectal Cancer, sponsored by BeiGene. Completed at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 33 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
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
200 milligrams (mg) administered through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles
Also known as: BGB-A317, TEVIMBRA®
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.
Time frame: Approximately 10 weeks after first dose of study treatment
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.
Time frame: 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.
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)
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.
Time frame: 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.
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.
Participants were enrolled in multiple study centers in China.
| Milestone | Tislelizumab |
|---|---|
| Started | 33 |
| Received surgery | 29 |
| Completed | 0 |
| Not completed | 33 |
| Withdrew: Study completed by sponsor | 30 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Death | 1 |
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.
| Percentage of Participants | Tislelizumab |
|---|---|
| Major Pathological Response (MPR) Rate | 89.7 (72.6 to 97.8) |
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.
| Percentage of Participants | Tislelizumab |
|---|---|
| Pathological Complete Response (pCR) Rate | 62.1 (42.3 to 79.3) |
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.
| Months | Tislelizumab |
|---|---|
| Event Free Survival (EFS) | NA (NA to NA) |
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.
| Percentage of Participants | Tislelizumab |
|---|---|
| 24 Months (2-Year) | 93.9 (77.9 to 98.4) |
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.
| Participants | Tislelizumab |
|---|---|
| TEAEs | 33 |
| Serious AEs | 4 |
| imAEs | 10 |
Collected over All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported 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; Maximum treatment duration was 2.3 months.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tislelizumab | 1/33 (3%) | 4/33 (12.1%) | 31/33 (93.9%) |
| Event | Tislelizumab |
|---|---|
| Cardiac arrestCardiac disorders | 1/33 |
| MyocarditisCardiac disorders | 1/33 |
| InflammationGeneral disorders | 1/33 |
| Skin infectionInfections and infestations | 1/33 |
| Event | Tislelizumab |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 18/33 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 11/33 |
| Wound complicationInjury, poisoning and procedural complications | 9/33 |
| Weight decreasedInvestigations | 6/33 |
| NauseaGastrointestinal disorders | 5/33 |
| FatigueGeneral disorders | 5/33 |
| C-reactive protein increasedInvestigations | 5/33 |
| HyperglycaemiaMetabolism and nutrition disorders | 5/33 |
| Sinus bradycardiaCardiac disorders | 4/33 |
| HyperthyroidismEndocrine disorders | 4/33 |
The Safety Analysis Set included all enrolled participants who received ≥ 1 dose of study drug
| Age, Continuous(years) | Tislelizumab |
|---|---|
| Mean | 51.9 ± 16.30 |
| Sex: Female, Male(Participants) | Tislelizumab |
|---|---|
| Female | 19 |
| Male | 14 |
| Race/Ethnicity, Customized(Participants) | Tislelizumab |
|---|---|
| Chinese | 33 |
| Region of Enrollment(participants) | Tislelizumab |
|---|---|
| China | 33 |
| The Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Tislelizumab |
|---|---|
| 0 (fully Active) | 27 |
| 1(Restrictive but Ambulatory) | 6 |
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Supporting information: Study protocol, Sap, Csr
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