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POSITRON: The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05615103
Collaborator
The First Afiiliated Hospital of Shantou University Medical College (Other), Shenzhen People's Hospital (Other), The Affiliated Cancer Hospital of Guangzhou Medical University (Other)
100
Enrollment
1
Location
13
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Treatment with immune checkpoint inhibitors such as programmed death receptor 1 (PD-1 inhibitors) for advanced and metastatic esophageal squamous cell carcinoma (ESCC) significantly improves patients' overall survival compared to chemotherapy alone. Despite this milestone breakthrough, immunochemotherapy also has known limitations. Indeed, only 45-72% of patients achieved objective responses. It is urgent to find out easily-determined and convenient biomarkers to identify patients who will benefit from such treatment modality. Due to the luminal structure of the esophagus, the exact diameter of esophageal tumor cannot be precisely measured per RECIST 1.1. Moreover, the definition of the metastatic lymph node in which the short-axis lengths should be longer than 1.5 cm hinders the risk of missing the smaller metastatic lymph node foci. Thus, it is difficult to implement morphology-based criteria for evaluating the neoadjuvant immunochemotherapy response. The current study aimed to investigate the role of iPERCIST in predicting tumor response and the short-term overall survival of patients with locally advanced ESCC after neoadjuvant immunochemotherapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Efficiency of 18F-FDG PET-CT for Predicting Advanced Oesophageal Squamous Cell Carcinoma Patients' Tumor Response to Immunochemotherapy in the Neoadjuvant Setting
    Actual Study Start Date :
    Nov 8, 2022
    Anticipated Primary Completion Date :
    Sep 8, 2023
    Anticipated Study Completion Date :
    Dec 8, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Pathologic complete response rate (pCR) [Three to five working days after surgery]

      The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

    Secondary Outcome Measures

    1. Overall survival [from the date of diagnosis to the date of death, assessed up to 100 months]

      Overall survival rate

    2. Event-free survival [from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months]

      EFS

    3. Safety as measured by number of participants with Grade 3 and 4 adverse events [Up to 12 weeks]

      Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 78 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • pathologically confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after neoadjuvant immunochemotherapy.

    • treatment-naïve and had the adequate cardiopulmonary function

    Exclusion Criteria:

    • previous autoimmune disease

    • unable to complete planned treatment courses and no complete follow-up PET-CT scan

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Guangdong Provincial People's Hospital
    • The First Afiiliated Hospital of Shantou University Medical College
    • Shenzhen People's Hospital
    • The Affiliated Cancer Hospital of Guangzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangdong Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05615103
    Other Study ID Numbers:
    • POSITRON
    First Posted:
    Nov 14, 2022
    Last Update Posted:
    Nov 29, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Nov 29, 2022