Personalized DC Vaccine for Postoperative Cancer

Phase 1

Recruiting

• Conditions: Colon Rectal Cancer; Gastric Cancer; Hepatocellular Carcinoma; Non-Small-Cell Lung Cancer
• Interventions: Biological: DC vaccine subcutaneous administration

• Registration Number: NCT04147078
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-08-24
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cell_therapy	DC vaccine subcutaneous administration	tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times

Primary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	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

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

Trial Locations

Locations (1)

Qiu Li; 🇨🇳 Chengdu, Sichuan, China