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Neoantigen-loaded DC Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment

NCT06751849 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-30

No results posted yet for this study

Summary

In this study, the investigators provide a combined treatment of personalized tumor neoantigen-loaded dendritic cell (DC) vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after second-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.

Conditions

  • Advanced NSCLC

Interventions

RADIATION

Radiotherapy

Radiotherapy will be completed prior to the administration of personalized tumor neoantigen-loaded DC vaccine and PD-1 inhibitors. The treatment cycle, frequency, and dosage are determined by the subject's primary physician based on the specific conditions of the participant.

DRUG

PD-1 inhibitor

Treatment with PD-1 inhibitors will begin after the completion of radiotherapy, with a treatment cycle of 3 weeks. On the first day (D1) of each treatment cycle, the drug is administered intravenously, with the dosage according to the instructions.

DRUG

Neoantigen-loaded DC vaccine

The treatment with personalized tumor neoantigen-loaded DC vaccine is divided into two periods: the primary phase and the boost phase. The primary phase consists of 6 treatments, with the first 3 treatments spaced one week apart and the subsequent 3 treatments spaced two weeks apart. Vaccine will be administrated on the fourth day (D4) of that week. The boost phase consists of 4 treatments, each spaced three weeks apart. Vaccine will be administrated on the fourth day (D4) of that week.

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2026-03-10
Completion
2026-06-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06751849 on ClinicalTrials.gov