NCT07458529招募中2 期
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)
Seventh Medical Center of PLA General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月10日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pCR rate
研究概览
简要总结
This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).
详细描述
Patients with clinically staged II-III pMMR/MSS locally advanced rectal adenocarcinoma (≤10 cm from anal verge) will receive long-course chemoradiotherapy (50 Gy/25 fractions) with concurrent Capecitabine, followed by two cycles of CapeOX chemotherapy and Tislelizumab (200 mg IV every 3 weeks). Participants will be randomized to receive either daily oral Probio-M9 (2 g) or matched placebo from treatment initiation until surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years
- •ECOG performance status 0-2
- •Biopsy-proven rectal adenocarcinoma
- •Distal tumor margin within 10 cm of the anal verge
- •No distant metastasis
- •Clinical stage II or III based on MRI (T4b excluded)
- •Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or MRI (measurable lesion according to RECIST 1.1)
- •Willing and able to comply with the study protocol
- •Willing to provide blood and tissue specimens for research purposes
- •No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)
- •No history of immune system disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, HIV infection, etc.)
- •No significant dysfunction of major organs (heart, lung, liver, kidney)
- •No jaundice or gastrointestinal obstruction
- •No acute or ongoing infection
- •Adequate hematologic and biochemical function including:
- •Neutrophils ≥ 1.5 × 10^9/L
- •Hemoglobin ≥ 80 g/L
- •Platelets ≥ 100 × 10^9/L
- •Serum creatinine ≤ 1.5 × ULN
- •Total bilirubin ≤ 1.5 × ULN
- •ALT and AST ≤ 2.5 × ULN
- •No social or psychiatric disorders that may interfere with study participation
- •Women of childbearing potential must have a negative pregnancy test before enrollment and must use effective contraception from study entry until 60 days after the last dose of study drug
排除标准
- •History of multiple primary cancers or concomitant malignant tumors other than rectal cancer
- •Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years
- •History of recent major surgery
- •Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)
- •Uncontrolled or severe concomitant diseases of any kind
- •Known allergy or hypersensitivity to any components of the study drugs
- •Estimated life expectancy ≤ 5 years due to any cause
- •Planned or prior organ or bone marrow transplantation
- •Use of immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment
- •History of central nervous system disorders that may impair the ability to provide informed consent or affect compliance with oral medication (investigator discretion)
- •Other conditions that may interfere with study results or lead to premature discontinuation of study treatment (e.g., alcoholism or drug abuse)
- •Pregnant or breastfeeding women, or women planning to become pregnant during the treatment period
研究组 & 干预措施
CRT+PD-1 inhibitor+Probio-M9
Experimental
干预措施: CRT+PD-1 inhibitor+Probio-M9 (Combination Product)
CRT+PD-1 inhibitor+placebo
Placebo Comparator
干预措施: CRT+PD-1 inhibitor+placebo (Combination Product)
结局指标
主要结局
pCR rate
时间窗: within 10 days after surgery
pathological complete response rate
次要结局
- 2-y OS rate(2 year)
- 2-y DFS rate(2 year)
- 3-y OS rate(3 year)
- 3-y DFS rate(3 year)
- 5-y OS rate(5 year)
- 5-y DFS rate(5 year)
- immune-related adverse event rate(from commencing of PD-1 inhibition to the 30th day after surgery)
- Changes in Gut Microbiota Composition(Stool samples will be collected at baseline (Day 1), Day 25 during treatment, and prior to surgery.)
研究者
研究点 (1)
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