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 cancer and non-small cell lung cancer
Primary objectives: Assessing the safety and tolerability of mRNA personalized tumor vaccines encoding neoantigen for unresectable or metastatic advanced esophageal and non-small cell lung cancers with standard treatment failure or no standard treatment. Secondary objectives: Preliminary observation of the efficacy of mRNA personalized tumor vaccines encoding neoantigen for unsurgically resected or metastatic advanced esophageal and non-small cell lung cancers with standard treatment failure or no standard treatment. Time of tumor progression (TTP); Disease Control Rate (DCR); Objective Remission Rate (ORR); Overall Survival (OS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
subcutaneous injection with personalized mRNA tumor vaccine
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v4.03
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 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 Neutropenia, thrombocytopenia Liver and kidney dysfunction
Time frame: 24 weeks
Disease Control Rate (DCR)
Disease Control Rate of Personalized mRNA Tumor Vaccine
Time frame: 1.5 years
Progression-free Survival (PFS)
Progression-free Survival of Personalized mRNA Tumor Vaccine
Time frame: 2 years
Time to Tumor Progression (TTP)
Time to Tumor Progression of Personalized mRNA Tumor Vaccine
Time frame: 2 years
Overall Survival (OS)
Overall Survival of Personalized mRNA Tumor Vaccine
Time frame: 3 years
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