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Verified·NCT02496273Synced: Oct 9, 2026Active, not recruitingPhase 1

Phase I Trial of CEA Specific AAV-DC-CTL Treatment in Stage IV Gastric Cancer

Plain-language summary

This Phase 1 study tests CEA-specific cytotoxic T lymphocytes (CTLs), induced by dendritic cells infected with a recombinant adeno-associated virus (AAV) carrying the CEA gene, in patients with stage IV gastric cancer. The aim is to evaluate clinical safety and preliminary efficacy. Participants must be 18 or older with stage IV gastric cancer, a life expectancy of at least 6 weeks, a Karnofsky score of at least 80, and serum CEA of at least 20 ng/ml.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase
Phase 1
Status
Active, not recruiting
Sponsor
The First People's Hospital of Changzhou
Intervention
CTL (CEA Specific Cytotoxic T-Lymphocytes)
Start date
1/1/2016
Estimated completion
12/1/2030

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Stage IV Gastric Cancer
* Patients with life expectancy greater than or equal to 6 weeks.
* Patients with a Karnofsky score of greater than or equal to 80.
* serum CEA ≥ 20ng/ml.
* Patient provides consent for all required biopsies.

Exclusion Criteria:

* Patients with severe active infection.
* Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
* Patients with HBV,HCV,HIV infection.
This is not medical advice. Consult your specialist.
View the official record on ClinicalTrials.gov →