An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR/MSI-H Stage II-III Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, ECOG performance status score 0-
- •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.
排除标准
- •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.
研究组 & 干预措施
dMMR/MSI-H CRC
Patients with dMMR/MSI-H stage II-III colorectal cancer who received neoadjuvant treatment with tislelizumab
结局指标
主要结局
Pathological complete response
时间窗: Up to 3 weeks after surgery
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after neoadjuvant treatment with tislelizumab.
Treatment emergent adverse events
时间窗: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
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.
次要结局
- Clinical complete response(Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
- Event free survival(Up to 2 years)
- Overall survival(Up to 5 years)
- Treatment related adverse events(Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
- Immunotherapy related adverse events(Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
研究者
LIN YANG
Prof
Cancer Institute and Hospital, Chinese Academy of Medical Sciences