NCT04636008招募中1 期
The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H/dMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse reaction
研究概览
简要总结
This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.
详细描述
The patients meet the inclusion criteria. After signing the informed consent, they are given radiotherapy 5Gyx5 and sintilimab 200mg ivgtt D1, D15, D29. Radical surgery is performed 6-8 weeks after radiotherapy.
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
- •Histologically confirmed rectal adenocarcinoma;
- •With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;
- •Not received any anti-rectal cancer treatment previously; for patients with Lynch syndrome, not received any anti-tumor therapy about rectal cancer diagnosed this time;
- •No distant metastasis except for lateral lymph nodes on thoracic and abdominal enhanced computed tomography (CT) scans; the distance between tumor's lower edge and anus within 15cm; clinical T stage ≥T2 on high-resolution pelvic magnetic resonance imaging (MRI)；
- •Men and women ≥18 years of age;
- •Eastern Cooperative Oncology Group performance status score 0 or 1;
- •Adequate hematologic, hepatic, renal, thyroid and cardiac function: hemoglobin ≥90 g/L, neutrophils ≥1500/mm3, platelets ≥75,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.5 × ULN; creatinine ≤1.5 × ULN, creatinine clearance ≥50 mL/min; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; serum albumin ≥28 g/L；thyroid stimulating hormone and free thyroxine within ±10% of normal levels; no obvious abnormality in electrocardiogram;
- •Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion;
- •Informed consent form signed;
- •Life expectancy of ≥3 months.
排除标准
- •Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;
- •Other malignancy history with disease free survival <5 years, except for curative in situ cervical cancer, curative skin basal cell carcinoma and curative gastrointestinal cancer by endoscopic mucoresection;
- •Current or past history of autoimmune diseases, including but not limited to: interstitial lung disease, uveitis, enteritis，active hepatitis (HBV DNA≥103 copies/mL after regular antiviral therapy)，nephritis, hyperthyroidism and hypothyroidism;
- •Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;
- •Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al;
- •Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies/mL after regular antiviral therapy);
- •Having one of the following complications: massive gastrointestinal hemorrhage, gastrointestinal perforation or obstruction; symptomatic heart diseases including unstable angina, myocardial infarction and heart failure; uncontrollable diabetes mellitus or hypertension; uncontrollable diarrhea (interfering with daily activities although receiving adequate treatment);
- •Bleeding tendency or receiving thrombolytic or anticoagulant therapy;
- •Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures;
- •Psychiatric disorders that would interfere with cooperation with the requirements of the study;
- •Other conditions that investigators consider not suitable for this study.
研究组 & 干预措施
Experimental arm
Experimental
Sintilimab+Hypofractionated radiotherapy
干预措施: Sintilimab (Drug)
Experimental arm
Experimental
Sintilimab+Hypofractionated radiotherapy
干预措施: Hypofractionated Radiotherapy (Radiation)
结局指标
主要结局
Adverse reaction
时间窗: up to 10 weeks
Adverse reaction after receiving treatment of Sintilimab combined with hypofractionated radiotherapy and perioperative complications
次要结局
- Pathological response rate(6-8 weeks after radiotherapy)
- Complete resection rate(6-8 weeks after radiotherapy)
- Quality of life questionnaire(up to 10 weeks)
研究者
研究点 (1)
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