Personalized DC Vaccine for Postoperative Cancer

Sichuan University

Status and phase: Enrolling; Phase 1

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

Treatments: Biological: DC vaccine subcutaneous administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04147078

CHANT-191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

cell_therapy

Experimental group

Description:

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

Treatment:

Biological: DC vaccine subcutaneous administration