Preoperative Short Course Radiotherapy With Consolidation Chemotherapies and Camrelizumab Followed by Delayed Surgery in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 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 is a open-label, single-arm study to investigate the safety and efficacy of consolidative chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.
详细描述
Patients with locally advanced rectal cancer (cT3-4 or N+) are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with consolidation chemotherapy consisting two cycles of CAPOX chemotherapy and camrelizumab, an anti-PD-1 antibody drug for two cycles. Subsequent surgical therapy is performed to evaluate the safety and efficacy.
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
- •Patients who personally provided written consent for participation in the study
- •Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT
- •Primary rectal cancer histopathologically confirmed to be adenocarcinoma
- •Clinical stage of T3/T4 or N positive and M0,before CRT
- •Patients with the ECOG performance status of 0 or 1 at the time of enrollment
- •Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy
- •Male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug
排除标准
- •Patients with recurrent rectal cancer or a history of pelvic radiation
- •Patients with a history of inflammatory bowel disease
- •Patients with a history of pneumonitis or interstitial lung disease
- •Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- •Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
- •Patients with a history of thyroid dysfunction
- •Patients with a history or finding of cardiovascular risk
- •Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody
- •Patients who are pregnant or lactating or who may be pregnant
- •Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study
研究组 & 干预措施
Chemotherapy and PD1 inhibitor
CAPOX (2 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine:Dose of 2000mg/m2,14days, q3w Camrelizumab (2 cycles): 200mg on day 1 of each cycle, q3w Surgical therapy: the resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR).
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Pathological complete response
时间窗: 1 year
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
次要结局
- margin-free (R0) resection rate(1 years)
- 3-year event-free survival rate(3 years)
- safety, and quality of life(1 year)
- 3-year overall survival rate(3 year)
研究者
Tao Zhang
Chief of gastrointestinal oncology
Wuhan Union Hospital, China