Neoadjuvant Long-course Chemoradiotherapy Followed by PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- pCR rate
研究概览
简要总结
The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.
详细描述
Investigator designed a single-arm, open-label, phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) for locally advanced rectal cancer.Participants will accept capecitabine-based long-term radiotherapy(50.4Gy radiation) followed by 200mg Sintilimab each time for 3 times, with 2-week intervals. The primary endpoint is pCR rate, and secondary endpoints include sphincter-preserving rate, adverse event rates.
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
盲法说明
Masking is not practically possible
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
- •aged 18~75
- •ECOG score 0~2
- •biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
- •no distant metastasis, staged II/III (T4b excluded) by MRI
- •maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MR
- •willing and able to comply with study protocol
- •consent to the use of blood and tissue specimens for study
- •no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.)
- •no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.)
- •no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.)
- •no jaundice or gastrointestinal obstruction
- •no acute/ongoing infection
- •no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN
- •no social or mental disorder
- •for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required
排除标准
- •multiple cancers, or with concomitant malignant tumors besides rectal cancer
- •having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
- •history of recent major surgery
- •with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
- •with uncontrolled, severe, concomitant diseases of any sort
- •allergic to any of the ingredients under study
- •estimated survival ≤ 5 years due to any reason
- •preparing for or having previously received organ or bone marrow transplant
- •having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion
- •for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient or oral medication compliance
- •with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.)
- •pregnant or lactating women, or women intending on conception during treatment period
研究组 & 干预措施
nCRT+PD-1
Long-course chemoradiation followed by PD-1 inhibition (Sintilimab 200mg, 3 times, 2-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 6 weeks after completion of radiation.
干预措施: radiation (Radiation)
nCRT+PD-1
Long-course chemoradiation followed by PD-1 inhibition (Sintilimab 200mg, 3 times, 2-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 6 weeks after completion of radiation.
干预措施: PD-1 Monoclonal Antibody (Drug)
nCRT+PD-1
Long-course chemoradiation followed by PD-1 inhibition (Sintilimab 200mg, 3 times, 2-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 6 weeks after completion of radiation.
干预措施: TME surgery (Procedure)
结局指标
主要结局
pCR rate
时间窗: within 1 week after surgery
pathological complete response rate
次要结局
- immune-related adverse event rate(from commencing of PD-1 inhibition to the 30th day after surgery)
- treatment-related adverse event rate(from commencing of treatment to the 30th day after surgery)
- incidence rate of surgical complications(within 30 days after surgery)
- sphincter preserving rate(instantly after surgery)
研究者
Shen Zhanlong
Department of Gastroenterological Surgery
Peking University People's Hospital