A Single-Arm, Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Early-Stage (Stage II-III) Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- Major Pathological Response (MPR) Rate
研究概览
简要总结
The main purpose of this study was to help meet the medical needs of people in China with certain types of solid tumors that have specific genetic changes called microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR). The study looked at how well the drug tislelizumab works and how safe it is when given before surgery (neoadjuvant treatment) for these types of tumors.
详细描述
This study enrolled participants with Stage II or III resectable colorectal cancer (CRC). Participants with unknown microsatellite instability (MSI) or mismatch repair (MMR) status provided blood and tumor tissue samples during a prescreening period (within 56 days before the first dose) for central laboratory confirmation of MSI status. Participants with known MSI-high (MSI-H) or deficient MMR (dMMR) status by local laboratory also underwent central confirmation when tumor samples were available. Eligible participants received tislelizumab 200 mg by intravenous infusion once every 3 weeks for 3 cycles as neoadjuvant therapy. After completion of neoadjuvant treatment, participants underwent complete surgical removal (R0 resection) of their tumor, and surgical specimens were assessed for pathological response, including major pathological response (MPR) and pathological complete response (pCR). Post-surgery, participants continued adjuvant therapy and follow-up as determined by their investigator.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Participants had a pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III colon or rectal cancer (CRC) with microsatellite instability-high (MSI-H) status confirmed by a sponsor-designated central laboratory, or known MSI-H status confirmed by a local laboratory. Participants were required to be eligible for complete surgical removal of the tumor (R0 resection) with curative intent.
- •Participants had evaluable or measurable disease as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.
- •Participants had adequate blood counts and organ function, as defined by protocol-specified laboratory test results obtained within 7 days before the first dose of study treatment.
排除标准
- •Participants had received any prior treatment for their current colorectal cancer, including chemotherapy, radiotherapy, or immunotherapy.
- •Participants had any condition requiring systemic treatment with corticosteroids at doses greater than 10 milligrams (mg) of prednisone per day, or other immunosuppressive medications within 14 days before the first dose.
- •Participants had active autoimmune diseases or a history of autoimmune diseases that could potentially relapse.
- •Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
研究组 & 干预措施
Tislelizumab
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Major Pathological Response (MPR) Rate
时间窗: Approximately 10 weeks after first dose of study treatment
MPR rate is defined as the percentage of participants whose resected primary tumor shows 10% or less remaining viable cancer cells after completing neoadjuvant therapy.
次要结局
- Pathological Complete Response (pCR) Rate(Approximately 10 weeks after first dose of study treatment)
- Event Free Survival (EFS)(From first dose to final analysis data cutoff (03JAN2025), disease progression, initiation of a new anticancer therapy, or death; whichever came first. Median follow-up was 21.7 months.)
- 2-Year and 3-Year Event Free Survival (EFS)(24 months and 36 months after first dose)
- Number of Participants Experiencing Adverse Events(From the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first (up to 03JAN2025). Maximum treatment duration was 2.3 months.)