Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03807102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-29
First Post:
2019-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer
Sponsor:
Yongchang Zhang
Organization:
Study Overview
Official Title:
Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TVATLC01
Brief Summary:
Tumor vaccines may make the body build an immune response to kill tumor cells. This research study is evaluating a new type of tumor vaccine termed as "Neoantigen Tumor Vaccine". The purpose of this phase I/II trial study is to assess the safety and effectiveness of neoantigentumor vaccine in post radical operation patients with stage IIIA lung cancer.
Detailed Description:
Outline: After successful vaccine manufacturing, patients receive neoantigen tumor vaccine hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years). Treatment continues in the absence of disease recurrence and metastasis or unacceptable toxicity.
Patients are followed for 2 years or up to the absence of disease recurrence and metastasis.
Projected accrual: A total of 30 patients will be accrued for this study.
Patients are followed for 2 years or up to the absence of disease recurrence and metastasis.
Projected accrual: A total of 30 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: