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Trail of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer (TVATLC01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807102
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Shanghai Houchao Biotechnology Co., Ltd
Information provided by (Responsible Party):
Wenxiang Wang, Hunan Province Tumor Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: Tumor Vaccine Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer
Estimated Study Start Date : January 16, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tumor Vaccine
Injection of NeoAntigen Tumor Vaccine
 Biological: Tumor 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).


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free Survival (DFS) [ Time Frame: Approximately 2 years ]
    The time that participants stay free of cancer after surgery following administration of tumor vaccine

  2. Adverse Events (AEs) [ Time Frame: 30 days from first study vaccine administration ]
    Number of participants experiencing clinical and laboratory adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807102


Contacts
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Contact: Nong Yang, MD +86 731 89762323 yangnong0217@163.com

Locations
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China, Hunan
Hunan Provincal Tumor Hospital
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Wenxiang Wang
Shanghai Houchao Biotechnology Co., Ltd
Investigators
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Principal Investigator: Wenxiang Wang, MD, PhD Hunan Provincal Tumor Hospital
More Information
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Responsible Party: Wenxiang Wang, MD, pHD, Director of Thoracic Surgery Department II, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT03807102    
Other Study ID Numbers: TVATLC01
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenxiang Wang, Hunan Province Tumor Hospital:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases