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Personalized DC Vaccine for Postoperative Cancer

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ClinicalTrials.gov Identifier: NCT04147078
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Zhen-Yu Ding, Sichuan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Hepatocellular Carcinoma Non-Small-Cell Lung Cancer Colon Rectal Cancer Biological: DC vaccine subcutaneous administration Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Treatment in Cancer Patients With Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147078


Contacts
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Contact: Qiu Li +86 028-85422589 liqiu@scu.edu.cn

Locations
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China, Sichuan
Qiu Li Recruiting
Chengdu, Sichuan, China, 610041
Contact: Qiu Li, PhD    +86 028-85422589    liqiu@scu.edu.cn   
Contact: Qiu Li    +86 028-85422589    liqiu@scu.edu.cn   
Sponsors and Collaborators
Sichuan University

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Responsible Party: Zhen-Yu Ding, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Sichuan University
ClinicalTrials.gov Identifier: NCT04147078     History of Changes
Other Study ID Numbers: SI2019175
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhen-Yu Ding, Sichuan University:
Cell therapy
safety
clinical efficacy
adjuvant treatment
locally advanced cancer
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs