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A Real World Study of the Treatment of Gastric Adenocarcinoma With Huachansu

Sponsor
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05249244
Collaborator
(none)
1,000
Enrollment
1
Location
8
Anticipated Duration (Months)
125.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of huachansu oral preparation in the treatment of inoperable locally advanced or advanced metastatic gastric adenocarcinoma, including gastric esophageal adenocarcinoma.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this multicenter, controlled, retrospective, real-world study, the original medical records of participants diagnosed with inoperable locally advanced or advanced metastatic gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) receive treatment in research centers from January 1, 2014 to December 31, 2019 were collected. To evaluate the efficacy and safety of oral huachansu in the systematic treatment of locally advanced or advanced metastatic gastric adenocarcinoma.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Real World Study of the Treatment of Locally-inoperable Advanced or Advanced Metastatic Gastric Adenocarcinoma With Huachansu
    Actual Study Start Date :
    Jul 1, 2021
    Actual Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Feb 28, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    observation group

    huachansu oral preparation (tablet, capsule) was used.
    control group

    huachansu was not used.

    Outcome Measures

    Primary Outcome Measures

    1. OS [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

      overall survival

    2. AE;SAE [1 year, year 1]

      adverse event;Serious Adverse Event

    Secondary Outcome Measures

    1. ADR;SADR [1 year, year 1]

      Adverse Drug Reaction;Serious Adverse Drug Reaction

    Other Outcome Measures

    1. ORR [through study completion]

      ORR=CR+PR

    2. DCR [through study completion]

      DCR=CR+PR+SD

    3. PFS [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

      progression-free survival

    4. BMI [through study completion]

      BMI=weight（kg）/height²（m²）

    5. Use of painkillers during treatment [through study completion]

      Proportion of patients using painkillers during treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Only patients who meet all the following criteria are included in the study:

    1. Diagnosed with gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) by histopathology or cytology at the enrolled centers From January 1, 2014 to December 31, 2019.

    2. Stage of disease (clinical or pathological stage) is locally advanced or advanced (stage IIIB-IV) .

    3. The doctor judged that the tumor tissue was unresectable.

    4. At least two medical records.

    5. At least one huachansu oral preparation (tablet, capsule) was used during treatment (observation group only) .

    Exclusion Criteria:
    Patients who meet any of the following criteria are not allowed to enter the test:

    1. Lack of clinical data related to important research indicators (survival).

    2. Refusal to cooperate with follow-up.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Anhui Medical University Hefei China

    Sponsors and Collaborators

    • China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: kangsheng gu, The First Affiliated Hospital of Anhui Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05249244
    Other Study ID Numbers:
    • ICM-HCS-CR01
    First Posted:
    Feb 21, 2022
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Feb 21, 2022