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Recruiting NCT06751940

Neoantigen-loaded DC Vaccine and Conventional Second-line Therapy for CRC Progressed After First-line Treatment

Trial Parameters

Condition Colorectal Cancer (CRC)
Sponsor The First Affiliated Hospital of Nanchang University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-09-01
Completion 2026-08-31
Interventions
Conventional second-line therapyNeoantigen-loaded DC vaccine

Brief Summary

In this study, the investigators provide a combined treatment of personalized tumor neoantigen-loaded DC vaccine and conventional second-line therapy to patients with colorectal cancer (CRC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.

Eligibility Criteria

Inclusion Criteria: * Patients with histologically or cytologically confirmed CRC; * At least one measurable lesion; * Aged 18-70, regardless of gender; * Disease progression after standard first-line therapy, and more than 2 weeks since the end of the last antitumor treatment; * Expected survival of ≥3 months; * ECOG performance status of 0-1; * Female patients of childbearing age must have a negative pregnancy test and be able to take effective contraceptive measures with no plans for pregnancy within six months of the study; * Able to undergo all screening period laboratory tests as required by the protocol; * Normal major organ function, such as heart, liver, and kidney; * Hematologic parameters: neutrophil count ≥1.5×10\^9/L, hemoglobin ≥10g/dL, platelet count ≥100×10\^9/L, total bilirubin ≤1.5 times the upper limit of normal, AST and ALT ≤2.5 times the upper limit of normal, creatinine and blood urea nitrogen ≤1.5 times the upper limit of normal, activated partial thromboplastin

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