Personalized DC Vaccine for Postoperative Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04147078
• Other study ID #: SI2019175
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2019
• Est. completion date: June 1, 2026

Study information

• Verified date: March 2024
• Source: Sichuan University
• Contact: Qiu Li
• Phone: +86 028-85422589
• Email: liqiu[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Colon Rectal Cancer
• Gastric Cancer
• Hepatocellular Carcinoma
• Non-Small-Cell Lung Cancer

Intervention

Biological:
• DC vaccine subcutaneous administration
subcutaneous administration

Locations

Country	Name	City	State
China	Qiu Li	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

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