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RICE-Chronos: Sequence and Time-of-day Infusion of immunoCHemotherapy Affect Response in Oesophageal Cancer in the NeOadjuvant Setting

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05615129
Collaborator
The First Affiliated Hospital of Shantou Univesity Medical College (Other), Peking University Shenzhen Hospital (Other)
350
Enrollment
1
Location
12.9
Actual Duration (Months)
27
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is reported that compared to chemotherapy alone, immunochemotherapy has significantly improved the overall survival of patients with advanced metastatic ESCC. However, there are still more than 30% of patients who cannot benefit from this treatment modality. In addition to these factors, the time-of-day infusion and administration sequence of immunochemotherapy have been reported to be associated with tumor responses and overall survival. In this study, The investigators aimed to explore the roles of infusion time and administration sequence of immunochemotherapy in predicting tumor responses and overall survival in patients with advanced ESCC.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    350 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Effect of Immunochemotherapy Sequence and Time-of-day Infusion on Efficacy and Prognosis of Patients With Advanced Esophageal Squamous Cell Carcinoma
    Actual Study Start Date :
    Oct 1, 2021
    Actual Primary Completion Date :
    Aug 30, 2022
    Actual Study Completion Date :
    Oct 30, 2022

    Outcome Measures

    Primary Outcome Measures

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

      Overall survival rate

    Secondary 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

    Eligibility Criteria

    Criteria

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

    • Pathologically diagnosed as esophageal squamous cell carcinoma

    • KPS≥80

    • Adequate organ function

    • No distant metastasis

    • The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist

    Exclusion Criteria:

    • incomplete medical record which affects statistical analysis

    • have participated in previous interventional clinical trials

    • other situations evaluated by investigators not meet the enrollment

    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 Affiliated Hospital of Shantou Univesity Medical College
    • Peking University Shenzhen Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangdong Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05615129
    Other Study ID Numbers:
    • RICE-Chronos
    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