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Observational Study on the Sensitivity of Neoadjuvant Immunotherapy in Early Triple-Negative Breast Cancer

NCT06448169 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-06-07

No results posted yet for this study

Summary

Studies have reported that tumors with the same immunogenic mutations may induce T cell receptor (TCR) domains with similar antigen recognition functions. By assembling the complementarity-determining region 3 (CDR3) of TCRs from RNA-seq data and correlating them with 9142 samples from TCGA data, an in-depth analysis of the TCR pool in the tumor microenvironment found a strong correlation between the CDR3 sequences of tumor-infiltrating T cells and tumor mutation burden. Fairfax et al. found that in patients responding to tumor immunotherapy, the TCR immune pool of CD8+ T cells produces many clones with extremely high abundance (exceeding 0.5%) . Cader et al. also found significant changes in the TCR immune pool of patients with Hodgkin's lymphoma responding to PD-1 tumor immunotherapy. Based on these theoretical foundations, evaluating the dynamic changes of the TCR immune pool is expected to be used to analyze the immune characteristics and changes in diseases such as malignant tumors.

Conditions

Interventions

DRUG

PD-1 inhibitor

PD-1 inhibitor combined with neoadjuvant chemotherapy

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • Shandong University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2026-02-28
Completion
2026-04-30

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Entities

Diseases

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 NCT06448169 on ClinicalTrials.gov