Trial of Tumor Vaccine Used for Adjuvant Therapy in Post... | NCT03807102

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

NCT03807102

Sponsor

Yongchang Zhang

Status

Unknown status

Last Update Posted

Dec 29, 2023Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Lung Cancer

Interventions

Tumor Vaccine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2024Estimated

Primary Completion Date

Jan 31, 2025Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Jan 4, 2019

First Submission Date that Met QC Criteria

Jan 12, 2019

First Posted Date

Jan 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 25, 2023

Last Update Posted Date

Dec 29, 2023Actual

Name	Class
Shanghai Houchao Biotechnology Co., Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tumor Vaccine	Experimental	Injection of NeoAntigen Tumor Vaccine	Biological: Tumor Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tumor Vaccine	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).	Tumor Vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free Survival (DFS)	The time that participants stay free of cancer after surgery following administration of tumor vaccine	Approximately 2 years
Adverse Events (AEs)	Number of participants experiencing clinical and laboratory adverse events	30 days from first study vaccine administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Nong Yang, MD	Contact	+86 731 89762323		yangnong0217@163.com

Name	Affiliation	Role
Wenxiang Wang, MD, PhD	Hunan Provincal Tumor Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hunan Provincal Tumor Hospital		Changsha	Hunan	410013	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures