Personalized DC Vaccine for Postoperative Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DC vaccine subcutaneous administration.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Hepatocellular Carcinoma, Non-Small-Cell Lung Cancer, Colon Rectal Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjuvant Treatment in Cancer Patients with Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
Overview
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.
Interventions
- Biological DC vaccine subcutaneous administration
subcutaneous administration
Primary outcome measures
- Disease-free Survival (DFS) [Time frame: Up to 5 years]
Secondary outcome measures (2)
- Overall Survival (OS) [Time frame: Up to 10 years]
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [Time frame: 3 months after the last administration of cells]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Qiu Li — Chengdu
Identifiers
NCT: NCT04147078 · CHANT-191