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

NCT06751914 · Status: RECRUITING · Phase: NA · 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-based peptide 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.

Conditions

  • Colorectal Cancer (CRC)

Interventions

COMBINATION_PRODUCT

Conventional 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.

DRUG

Neoantigen-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.

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
2024-09-01
Primary Completion
2026-08-31
Completion
2027-02-28

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 NCT06751914 on ClinicalTrials.gov