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Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06011993
Collaborator
(none)
30
Enrollment
1
Location
4.4
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy. Patients with untreated, operable, or potentially resectable HNSCC will be included.The pathological results, adverse events and other information of eligible patients will be collected.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）
    Actual Study Start Date :
    Jul 19, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events [6 months]

      Adverse events should be collected, followed up and reported in accordance with prescribed procedures.

    Secondary Outcome Measures

    1. Major Pathological Response [6 months]

      MPR, defined as ≤10% of residual surviving tumors

    2. Complete Pathological Response [6 months]

      CPR, defined as no residual survivable tumor cells

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18-80, male or female；

    • Cytologically or histologically diagnosed squamous cell carcinoma (except mixed squamous cell carcinoma)；

    • There was at least one radiographically measurable lesion according to the solid tumor response Evaluation Criteria (RECIST version 1.1)；

    • Patients with untreated, operable, or potentially resectable head and neck squamous cell carcinoma；

    Exclusion Criteria:

    • Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to first administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection)；

    • Currently participating in an interventional clinical study or has received another investigational drug or has used investigational devices in the 4 weeks prior to initial dosing；

    • Evidence of medical history or disease that may interfere with trial results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment；

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT06011993
    Other Study ID Numbers:
    • neoHNSCC
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    HNSCC
    Neoadjuvant immunochemotherapy
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck

    Study Results

    No Results Posted as of Aug 25, 2023