Personalized DC Vaccine for Postoperative Cancer

NCT04147078 | Recruiting Phase 1

• 1 other identifier: CHANT-191
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cell therapy; safety; clinical efficacy; adjuvant treatment; locally advanced cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival (DFS)

  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 Outcomes (2)

• Overall Survival (OS)

  Up to 10 years

• Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

  3 months after the last administration of cells

Study Arms (1)

cell_therapy

EXPERIMENTAL

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

Biological: DC vaccine subcutaneous administration

Interventions

DC vaccine subcutaneous administration BIOLOGICAL

subcutaneous administration

cell_therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

Qiu Li

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Qiu Li

CONTACT

+86 028-85422589; liqiu@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: October 31, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)