Personalized DC Vaccine for Postoperative Cancer

NCT ID: NCT04147078

Last Updated: 2025-02-28

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2026-06-01

Brief Summary

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The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.

Detailed Description

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Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

Conditions

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Gastric Cancer Hepatocellular Carcinoma Non-Small-Cell Lung Cancer Colon Rectal 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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cell_therapy

tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times

Group Type EXPERIMENTAL

DC vaccine subcutaneous administration

Intervention Type BIOLOGICAL

subcutaneous administration

Interventions

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DC vaccine subcutaneous administration

subcutaneous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation
* Anticipated life time \> 3month
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Adequate organ functions

Exclusion Criteria

* Any evidence of tumor metastasis or co-existing malignant disease
* Tumor emergency
* Abnormal coagulation condition
* Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
* Concomitant tumors
* Immunological co-morbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan University

OTHER

Sponsor Role lead

Responsible Party

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Zhen-Yu Ding

Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qiu Li

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiu Li

Role: CONTACT

+86 028-85422589

Facility Contacts

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Qiu Li, PhD

Role: primary

+86 028-85422589

Qiu Li

Role: backup

+86 028-85422589

Other Identifiers

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CHANT-191

Identifier Type: -

Identifier Source: org_study_id

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