Multicenter, Single-arm, Open-label Phase II Clinical Study of Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Percentage of Participants With Pathological Complete Response (pCR)
研究概览
简要总结
This study is a multi-center, single-arm, open-label phase II clinical trial, aiming to observe and evaluate the perioperative treatment of tislelizumab combined with chemotherapy (CAPOX) in stage II or III colorectal cancer with MSI-H/dMMR Patient efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG: 0~1;
- •Patients with colon or rectal adenocarcinoma confirmed by histology or cytology;
- •The tissue specimens are confirmed as MSI-H by PCR or NGS. If the patients are dMMR by immunohistochemistry, they need to be confirmed as MSI-H by PCR (2021 Expert Consensus on Immunotherapy for Patients with Colorectal Cancer);
- •Patients with clinical stage II or III (cT3-T4 N0 M0 or Tany N+M0, clinically positive lymph nodes are defined as any lymph node ≥ 1.0 cm);
- •Expected survival period ≥ 12 weeks;
- •The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits.
排除标准
- •Have received anti-tumor therapy;
- •Have received PD-(L)1 or CTLA-4 treatment;
- •The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma that has been completely remitted in childhood and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included);
- •Patients are using immunosuppressants or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other equivalent hormones), and continue to use within 2 weeks before enrollment;
- •Patients with any severe and/or uncontrolled diseases
- •Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity > 1.0g;
- •Pregnant or lactating women;
- •Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •Those who have a history of psychotropic drug abuse and cannot quit or patients with mental disorders;
研究组 & 干预措施
Tislelizumab combined with CAPOX
Successfully screened subjects will receive 4 cycles of neoadjuvant therapy with tislelizumab combined with chemotherapy (CAPOX) before surgery； undergo radical surgery 4-6 weeks after the end of the last medication; tislelizumab will be given after surgery Monoclonal antibody ± chemotherapy adjuvant therapy (the investigator judges whether to add chemotherapy based on the patient's comprehensive condition), until disease progression or unacceptable toxicity, the longest treatment is 12 months.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response (pCR)
时间窗: Up to 24 months
After receiving tislelizumab combined with CAPOX neoadjuvant, the rate of pathological complete remission (after neoadjuvant therapy, for those who insist on organ preservation, combined with imaging and endoscopic examination to achieve cCR, and the biopsy result of the microscope is pathological Complete remission can be judged as pCR)
次要结局
- R0 resection rates(Up to 24 months)
- Overall survival (OS)(Up to 36 months)
- Event-free survival (EFS)(Up to 36 months)
- Incidence of adverse events during the treatment and follow-up (safety)(until 100 days after last patient last study drug treatment)
研究者
Feng Wang
Head of the oncology ward
The First Affiliated Hospital of Zhengzhou University