Neoadjuvant Therapy With Tislelizumab for dMMR/MSI-H Stage II-III Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colo-rectal Cancer (dMMR/MSI-H CRC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR/MSI-H Stage II-III Colorectal Cancer
Overview
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.
Primary outcome measures
- Pathological complete response [Time frame: Up to 3 weeks after surgery]
- Treatment emergent adverse events [Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
Secondary outcome measures (5)
- Clinical complete response [Time frame: Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
- Event free survival [Time frame: Up to 2 years]
- Overall survival [Time frame: Up to 5 years]
- Treatment related adverse events [Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
- Immunotherapy related adverse events [Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years, ECOG performance status score 0-2.
- Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition).
- Histologically confirmed mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor.
- Signed written informed consent.
Exclusion criteria
- The patient has a history of other serious conditions rendering them unsuitable for surgery.
- 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.
- Known hypersensitivity to any component or excipient of tislelizumab or other PD-1/PD-L1 agents.
- Other conditions deemed unsuitable for inclusion by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07352280 · NCC5791