RecruitingNot ApplicableNCT06751940

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

A Multicenter Clinical Study of Personalized Tumor Neoantigen-loaded DC Vaccine Combined with Conventional Second-line Therapy for the Treatment of Colorectal Cancer Progressed After First-line Treatment


Sponsor

The First Affiliated Hospital of Nanchang University

Enrollment

10 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a personalized neoantigen-loaded dendritic cell (DC) vaccine — a vaccine made from the patient's own immune cells trained to target tumor mutations — to standard second-line chemotherapy improves outcomes for people with colorectal cancer that progressed after first-line treatment. **You may be eligible if...** - You have confirmed colorectal cancer that progressed after first-line therapy - You are between 18 and 70 years old - You are in good enough health to function (ECOG score 0–1) - Your major organs (heart, liver, kidneys, blood counts) are functioning adequately - Expected survival of at least 3 months **You may NOT be eligible if...** - You have active hepatitis, HIV/AIDS, syphilis, or other active infections - Your blood counts, liver, or kidney values fall outside required ranges - You are pregnant or planning to become pregnant within 6 months - It has been fewer than 2 weeks since your last cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTConventional second-line therapy

Conventional second-line therapy includes chemotherapy, targeted cancer drugs, and/or PD-1 inhibitors.The chemotherapy drugs, dosage and treatment cycle are determined by the subject's attending physician based on the subject's specific conditions. The medication, dosage and treatment cycle of targeted cancer drugs will be determined by the subject's attending physician based on the subject's specific circumstances. The PD-1 inhibitor treatment cycle is 3 weeks, and the drug is administered by intravenous infusion on the first day (D1) of each treatment cycle. The dosage is based on the instructions.

DRUGNeoantigen-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.


Locations(2)

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Nanchang

Nanchang, Jiangxi, China

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NCT06751940


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