Status:
NOT_YET_RECRUITING
Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer
Lead Sponsor:
Yongchang Zhang
Collaborating Sponsors:
Shanghai Houchao Biotechnology Co., Ltd
Conditions:
Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03807102
Start Date
January 16 2024
End Date
January 31 2026
Last Update
December 29 2023
Active Locations (1)
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1
Hunan Provincal Tumor Hospital
Changsha, Hunan, China, 410013