Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Esophageal Squamous Carcinoma
- Colorectal Adenocarcinoma
- Gastric Adenocarcinoma
- Pancreatic Adenocarcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
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 ...
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: Time of tumor progression (TTP); Disease Control Rate (DCR); Objective Remission Rate (ORR); Overall Survival (OS).
Tracking Information
- NCT #
- NCT03468244
- Collaborators
- Stemirna Therapeutics
- Investigators
- Study Director: Xianbao Zhan, Dr. Chanhai hospital