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

NCT ID: NCT03807102

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tumor Vaccine

Injection of NeoAntigen Tumor Vaccine

Group Type EXPERIMENTAL

Tumor Vaccine

Intervention Type BIOLOGICAL

NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).

Interventions

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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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Houchao Biotechnology Co., Ltd

UNKNOWN

Sponsor Role collaborator

Yongchang Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

MD, pHD, Director of Thoracic Surgery Department II

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenxiang Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hunan Provincal Tumor Hospital

Locations

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Hunan Provincal Tumor Hospital

Changsha, Hunan, China

Site Status

Countries

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China

Central Contacts

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Nong Yang, MD

Role: CONTACT

Phone: +86 731 89762323

Email: [email protected]

Other Identifiers

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TVATLC01

Identifier Type: -

Identifier Source: org_study_id