NCT07352280 Neoadjuvant Therapy With Tislelizumab for dMMR/MSI-H Stage II-III Colorectal Cancer
| NCT ID | NCT07352280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Colo-rectal Cancer (dMMR/MSI-H CRC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07352280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colo-rectal Cancer (dMMR/MSI-H CRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07352280 currently recruiting?
Yes, NCT07352280 is actively recruiting participants. Contact the research team at linyangcicams@126.com for enrollment information.
Where is the NCT07352280 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07352280 clinical trial?
NCT07352280 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 30 participants.
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