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出境医 / 临床实验 / Trail of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer (TVATLC01)

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

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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

Contacts
Layout table for location contacts
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
Layout table for investigator information
Principal Investigator: Wenxiang Wang, MD, PhD Hunan Provincal Tumor Hospital
Tracking Information
First Submitted Date  ICMJE January 4, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date January 16, 2019
Estimated Study Start Date  ICMJE January 16, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2019)
  • Disease-free Survival (DFS) [ Time Frame: Approximately 2 years ]
    The time that participants stay free of cancer after surgery following administration of tumor vaccine
  • Adverse Events (AEs) [ Time Frame: 30 days from first study vaccine administration ]
    Number of participants experiencing clinical and laboratory adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trail of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer
Official Title  ICMJE Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Tumor Vaccine
Injection of NeoAntigen Tumor Vaccine
Intervention: Biological: Tumor Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2023
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nong Yang, MD +86 731 89762323 yangnong0217@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03807102
Other Study ID Numbers  ICMJE TVATLC01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wenxiang Wang, Hunan Province Tumor Hospital
Study Sponsor  ICMJE Wenxiang Wang
Collaborators  ICMJE Shanghai Houchao Biotechnology Co., Ltd
Investigators  ICMJE
Principal Investigator: Wenxiang Wang, MD, PhD Hunan Provincal Tumor Hospital
PRS Account Hunan Province Tumor Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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