Personalized DC Vaccine for Postoperative Cancer

February 25, 2025 updated by: Zhen-Yu Ding, Sichuan University

Adjuvant Treatment in Cancer Patients with Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Qiu Li
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cell_therapy
tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times
Biological: DC vaccine subcutaneous administration
subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival (DFS)
Time Frame: Up to 5 years
Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 10 years
Defined by the time between the date of randomization and the date of death
Up to 10 years
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Time Frame: 3 months after the last administration of cells
Defined by treatment-related adverse events as assessed by CTCAE v4.0
3 months after the last administration of cells

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 24, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANT-191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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