Lung Cancer
Conditions
Keywords
Lung Cancer
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.
Interventions
BIOLOGICALTumor Vaccine
NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).
Sponsors
Shanghai Houchao Biotechnology Co., Ltd
Yongchang Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 to 70 years, Male or Female * Histological or cytologically diagnosis of lung adenocarcinoma * After surgical treatment (lobectomy and systematic lymph node dissection) * Pathological stage IIIA (According to the IASLC Lung Cancer Staging (eight Edition)) * Postoperative standard treatment (platinum-based double-drug adjuvant treatment with or without chemotherapy) or no adjuvant treatment * Have potential dynamic tumor biomarkers * Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure, agree to participate in long-term follow-up for up to 3 years
Exclusion criteria
* Age \< 18 or\< 70 years * Lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer * Without surgical treatment * Pathological stage I、II、IIIB、IIIC or IV (According to the IASLC Lung Cancer Staging (eight Edition)) * Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study vaccine * Drug or alcohol abusers * Pregnant or breast-feeding patients * History of immunodeficiency disease or autoimmune disease * Patients with chronic disease which is undergoing immune reagents or hormone therapy * Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy * Lack of availability of a patient for immunological and clinical follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival (DFS) | Approximately 2 years | The time that participants stay free of cancer after surgery following administration of tumor vaccine |
| Adverse Events (AEs) | 30 days from first study vaccine administration | Number of participants experiencing clinical and laboratory adverse events |
Countries
China
Contacts
Primary ContactNong Yang, MD
Outcome results
None listed