Clinical trial · Observational
Neoadjuvant Therapy With Tislelizumab for dMMR/MSI-H Stage II-III Colorectal Cancer
An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR/MSI-H Stage II-III Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite instability high (dMMR/MSI-H) locally advanced colorectal cancer. All patients will receive three cycles of tislelizumab neoadjuvant therapy followed by curative surgery. Postoperatively, based on surgical pathology, patients will receive adjuvant therapy with a regimen selected by the investigator or adopt a watch-and-wait strategy. The investigators will conduct a 5-year prospective follow-up. The investigators plan to enroll approximately 30 subjects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer (dMMR/MSI-H CRC) | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- dMMR/MSI-H CRC
- description
- Patients with dMMR/MSI-H stage II-III colorectal cancer who received neoadjuvant treatment with tislelizumab
Primary outcomes (2)
- measure
- Pathological complete response
- timeFrame
- Up to 3 weeks after surgery
- description
- The lack of all signs of cancer in tissue samples removed during surgery or biopsy after neoadjuvant treatment with tislelizumab.
- measure
- Treatment emergent adverse events
- timeFrame
- Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
- description
- Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years, ECOG performance status score 0-2. 2. Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition). 3. Histologically confirmed mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor. 4. Signed written informed consent. Exclusion Criteria: 1. The patient has a history of other serious conditions rendering them unsuitable for surgery. 2. Subjects with the following conditions: active autoimmune diseases, active infectious diseases, inflammatory bowel diseases; requiring long-term glucocorticoid or immunosuppressive therapy during treatment; history of immunodeficiency; history of organ transplantation or haematopoietic stem cell transplantation; severe interstitial pneumonia or pulmonary fibrosis. 3. Known hypersensitivity to any component or excipient of tislelizumab or other PD-1/PD-L1 agents. 4. Other conditions deemed unsuitable for inclusion by the investigator.
References
Publications (0)
Data not yet available