RecruitingNot ApplicableNCT06751966

Neoantigen-based Peptide Vaccine and Conventional Third-line Therapy for CRC Progressed After Second-line Treatment

A Multicenter Clinical Study of Personalized Tumor Neoantigen-based Peptide Vaccine Combined with Conventional Third-line Therapy for the Treatment of Colorectal Cancer Progressed After Second-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-based peptide vaccine and conventional third-line therapy to patients with colorectal cancer (CRC) 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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a personalized neoantigen peptide vaccine (made from mutations specific to a patient's own tumor) to standard third-line chemotherapy can improve outcomes for people with colorectal cancer that has progressed through two prior treatments. **You may be eligible if...** - You have confirmed colorectal cancer that progressed after standard second-line therapy - You are between 18 and 70 years old - You are in reasonably good health (ECOG score 0–1) - Your blood counts and organ function meet required standards - 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 or organ function values fall outside required ranges - You are pregnant or planning pregnancy 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_PRODUCTCombination Product: Conventional third-line therapy

Conventional third-line therapy includes oral chemotherapy drugs and/or targeted cancer drugs. The medication, dosage and treatment cycle of oral chemotherapy drugs and/or targeted cancer drugs will be determined by the subject's attending physician based on the subject's specific circumstances.

DRUGNeoantigen-based peptide vaccine

The treatment with personalized tumor neoantigen-based peptide 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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NCT06751966


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