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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tumor Vaccine
Sponsored by
Wenxiang Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunan Provincal Tumor Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tumor Vaccine

Arm Description

Injection of NeoAntigen Tumor Vaccine

Outcomes

Primary Outcome Measures

Disease-free Survival (DFS)
The time that participants stay free of cancer after surgery following administration of tumor vaccine
Adverse Events (AEs)
Number of participants experiencing clinical and laboratory adverse events

Secondary Outcome Measures

Full Information

First Posted
January 4, 2019
Last Updated
January 12, 2019
Sponsor
Wenxiang Wang
Collaborators
Shanghai Houchao Biotechnology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03807102
Brief Title
Trail of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer
Acronym
TVATLC01
Official Title
Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2019 (Anticipated)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenxiang Wang
Collaborators
Shanghai Houchao Biotechnology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumor Vaccine
Arm Type
Experimental
Arm Description
Injection of NeoAntigen Tumor Vaccine
Intervention Type
Biological
Intervention Name(s)
Tumor Vaccine
Intervention Description
NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).
Primary Outcome Measure Information:
Title
Disease-free Survival (DFS)
Description
The time that participants stay free of cancer after surgery following administration of tumor vaccine
Time Frame
Approximately 2 years
Title
Adverse Events (AEs)
Description
Number of participants experiencing clinical and laboratory adverse events
Time Frame
30 days from first study vaccine administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nong Yang, MD
Phone
+86 731 89762323
Email
yangnong0217@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenxiang Wang, MD, PhD
Organizational Affiliation
Hunan Provincal Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincal Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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