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Recruiting

NCT Number: NCT04147078

Personalized DC Vaccine for Postoperative Cancer

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.

Recruiting

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Key information

Conditions

Gastric Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Colon Rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Small-Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DC vaccine subcutaneous administration

Biological

subcutaneous administration

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 10 years

    Defined by the time between the date of randomization and the date of death

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Qiu Li

CONTACT

[email protected]

+86 028-85422589

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Oct 31, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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