NCT06026774招募中1 期
A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard Adjuvant Therapy in Subjects With Resected Digestive System Neoplasms
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
- Number of Participants with Adverse Events (AEs) [safety and tolerability]
研究概览
简要总结
The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.
详细描述
This is a single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 in combination with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.
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
- •Male or female, >/= 18 years old and </= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.
- •Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms listed below that can be radical resected. Subjects must be able to receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery. The toxic effects of previous anti-tumor treatments have returned to </= grade 1 defined by NCI-CTCAE v5.0 or to the level specified by the inclusion/
排除标准
- •Subjects with any of the following digestive system neoplasms:
- •a. Cholangiocarcinoma b. Pancreatic cancer c. Hepatocellular carcinoma d. Gastric cancer e. Colorectal carcinoma
- •3. Expected survival \>/= 6 months.
- •4. ECOG performance status score of 0 \~ 1.
- •5. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 0.5cm\*0.5cm of tissue required for surgical samples.
- •6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \>/= 50%.
- •7. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \>/= 1.5 × 10\^9/L, platelet count (PLT) \>/= 80 × 10\^9/L, hemoglobin (Hb) \>/= 90 g/L; serum total bilirubin (TBIL) \/= 28g/L, serum creatinine \/= 50mL/min, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \/= grade 3, heart failure within 8 weeks before the first dose of iNeo-Vac-R01 (New York Heart Association \[NYHA\] cardiac function \>/= grade II, myocardial infarction, unstable angina, stroke, transient ischemic attack, cardiac surgery (including coronary artery bypass grafting or percutaneous coronary intervention) within 8 weeks before the first dose of iNeo-Vac-R01, concomitant severe electrocardiogram abnormalities (such as ventricular flutter, ventricular fibrillation, multiform ventricular tachycardia, sick sinus syndrome, third degree atrioventricular block without pacemaker treatment, QTc \>/= 480ms, and other conditions evaluated by the investigators as severe abnormalities), hypertension with poor drug control (systolic blood pressure \>/= 160mmHg and/or diastolic blood pressure \>/= 100mmHg), or other cardiocerebrovascular diseases that have been evaluated by the investigators as unsuitable for participation in this trial.
- •11. Subjects with respiratory disease: previously or currently pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe asthma, pulmonary hypertension or severe impairment of lung function, etc.
- •12. Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.
- •13. Subjects with drug abuse; clinical or psychological or social factors that affect informed consent or research implementation.
- •14. Subjects with a history of allergies to immunotherapy or vaccines, or other potential immunotherapy allergies identified by the investigators.
- •15. Subjects identified that it is not suitable for enrollment or may not be able to complete this experiment for other reasons by the investigators.
- •16. Vulnerable groups, including individuals with mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women, etc.
研究组 & 干预措施
iNeo-Vac-R01 in combination with standard adjuvant therapy
Experimental
Subjects will receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery. Then subjects will receive iNeo-Vac-R01 via IH injection on Day 1 of each 21-day cycle for up to 9 cycles at an applicable dose, identified during the dose escalation phase of the study.
干预措施: iNeo-Vac-R01 in combination with standard adjuvant therapy (Biological)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) [safety and tolerability]
时间窗: 21 days after last iNeo-Vac-R01 dose
次要结局
- The proportion of subjects who have no disease recurrence at 12 months or 24 months after first dose of iNeo-Vac-R01.(12 months and 24 months after first dose of iNeo-Vac-R01)
- Neoantigen-specific T Cell Response [immunogenicity](12 months after first dose of iNeo-Vac-R01)
- Overall Survival (OS)(3 years after first dose of iNeo-Vac-R01)
- T Cell Subsets [immunogenicity](12 months after first dose of iNeo-Vac-R01)
- Recurrence Free Survival (RFS)(3 years after first dose of iNeo-Vac-R01)
- Cytokines Level [immunogenicity](6 months after first dose of iNeo-Vac-R01)
研究者
Xiujun Cai
The director of Sir Run Run Shaw Hospital
Sir Run Run Shaw Hospital
研究点 (1)
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