2018-05-01
2019-12-31
2021-12-31
24
NCT03468244
Changhai Hospital
Changhai Hospital
INTERVENTIONAL
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms
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
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-03-08 | N/A | 2019-02-25 |
2018-03-15 | N/A | 2019-02-26 |
2018-03-16 | N/A | 2019-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Personalized mRNA Tumor Vaccine Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma | BIOLOGICAL: Personalized mRNA Tumor Vaccine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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 | 24 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease Control Rate of Personalized mRNA Tumor Vaccine | Disease Control Rate (DCR) | 1.5 years |
| Progression-free Survival of Personalized mRNA Tumor Vaccine | Progression-free Survival (PFS) | 2 years |
| Time to Tumor Progression of Personalized mRNA Tumor Vaccine | Time to Tumor Progression (TTP) | 2 years |
| Overall Survival of Personalized mRNA Tumor Vaccine | Overall Survival (OS) | 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Bin Wang, Dr. Phone Number: +86 02131161448 Email: qcwangb@163.com |
Study Contact Backup Name: Xianbao Zhan, Dr. Phone Number: +86 02131161441 Email: zhanxianbao@126.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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