Clinical Study of Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma
详细描述
Dr. Bin Wang developed the investigational vaccine used in this clinical trial and designed the trial protocol.For patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma tumor who have disease progression with first line chemotherapy. Single or multiple doses of personalized mRNA tumor vaccine encoding neoantigen will be given to observe the safety and efficacy the mRNA tumor vaccine.
Primary objectives:
Determine the safety, tolerability and cytokinetics of the personalized mRNA tumor vaccine in patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma.
Secondary objectives:
Make a preliminary evaluation on the efficacy of personalized mRNA tumor vaccine in patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma with the following parameters:
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 aged 18 - 75 with pathologically confirmed advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma.
- •Patients with advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma who have disease progression with first line chemotherapy. (1) Failure of treatment is defined as disease progression, recurrence or metastatic disease, or intolerable toxicities occurred after treatment. (2) Each line of treatment during the period of disease progression includes one or more chemotherapy drugs which are administered for not less than one cycle or even longer. Neoadjuvant/adjuvant therapy can be applied at an earlier stage of treatment. If patient has developed recurrence or metastatic disease within 24 weeks of neoadjuvant/adjuvant therapy, it is considered as one line of systemic chemotherapy. (3) Therapies that can be performed at an earlier stage are chemotherapy in conjunction with molecular targeted drugs.
- •Expected survival after first dose of study drug > 24 weeks.
- •At least one measurable lesion (≥ 10 mm) for imaging assessment.
- •ECOG scores 0 -
- •Fresh pathological tissue specimens can be obtained
- •White blood cells (WBCs) ≥ 2.5×10^9/L
- •Platelets (PLT) ≥ 100×10^9/L
- •Hemoglobin, Blood (Hb) ≥ 9.0 g/dL
- •MID ≥ 1.5×10^9/L
- •Lymphocyte (LY) ≥ 0.47×10^9/L
- •LY% ≥ 15%
- •Serum albumin (Alb) ≥ 30 g/L
- •Serum lipase (LPS) and serum amylase < 1.5 ULN
- •Serum creatinine ≤ 1.5 ULN
- •Alanine aminotransferase (ALT) ≤ 2.5 ULN
- •Aspartate aminotransferase (AST) ≤ 2.5 ULN
- •If osseous metastasis or liver metastasis is developed and alkaline phosphatase • (ALP) > 2.5 ULN, ALT and AST < 1.5 ULN.
- •Serum total bilirubin (TBIL) ≤ 1.5 ULN
- •Prothrombin Time (PT): International Normalized Ratio (INR) < 1.
- •PT < (ULN + 4) s
- •All test results should be within their normal ranges, and the patient is not receiving continuous supportive care.
排除标准
- •Patients with any of the following conditions are not eligible for the study.
- •Pregnant or lactating women.
- •HIV positive, HCV positive, HBV DNA copies ≥ 10^
- •Uncontrolled active infection.
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- •Allergic to immunotherapies and related drugs.
- •Untreated brain metastases or having symptoms of brain metastases.
- •Metastases to the lung: central tumor or multiple metastases.
- •Patients with heart disease for which treatment is needed or with poorly controlled hypertension.
- •Patients with unstable or active peptic ulcer or with alimentary tract hemorrhage.
- •Patients with previous organ transplantation or in preparation for organ transplantation.
- •Patients have undertaken major surgeries or have been badly injured 4 weeks before the study (blood collection), or will undertake major surgeries during the study.
- •The judgment of investigators that the patient is not able to or not willing to follow the instructions of the protocol.
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 24 weeks
During the trial conduction, especially within the 24 weeks of treatment phase when mRNA tumor Vaccine administered, all adverse events (including laboratory abnormality and clinical events) will be closely monitored, and all ≥ grade 3 adverse events per CTCAE (v 3.0) will be recorded, including but not limited to the toxicities potentially suspected to relate to injection procedures and/or mRNA Tumor Vaccine therapy as listed below: * Fever * Chills * Nausea, vomiting and other gastrointestinal symptoms * Fatigue * Hypotension * Respiratory distress * Tumor lysis syndrome * Neutropenia, thrombocytopenia * Liver and kidney dysfunction
次要结局
- Disease Control Rate of Personalized mRNA Tumor Vaccine(1.5 years)
- Progression-free Survival of Personalized mRNA Tumor Vaccine(2 years)
- Overall Survival of Personalized mRNA Tumor Vaccine(3 years)
- Time to Tumor Progression of Personalized mRNA Tumor Vaccine(2 years)
研究者
Bin Wang
Attending physician
Changhai Hospital