Colon Rectal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Non-Small-Cell Lung Cancer
Conditions
Keywords
Cell therapy, safety, clinical efficacy, adjuvant treatment, locally advanced cancer
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.
Interventions
BIOLOGICALDC vaccine subcutaneous administration
subcutaneous administration
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 10 years | Defined by the time between the date of randomization and the date of death |
| 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 |
Countries
China
Contacts
Primary ContactQiu Li
Outcome results
None listed