Health TrialsbyHealthPanel

Personalized DC Vaccine for Postoperative Cancer

ConditionsGastric CancerHepatocellular CarcinomaNon-Small-Cell Lung CancerColon Rectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • DC vaccine subcutaneous administration

    Biological/Vaccine

    subcutaneous administration

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: cell_therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 5 years

Secondary outcomes

1

Overall Survival (OS)

Defined by the time between the date of randomization and the date of death

Time frame
Up to 10 years
2

Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

Defined by treatment-related adverse events as assessed by CTCAE v4.0

Time frame
3 months after the last administration of cells

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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