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

February 18, 2022 updated by: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

A Real World Study of the Treatment of Locally-inoperable Advanced or Advanced Metastatic Gastric Adenocarcinoma With Huachansu

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with locally inoperable advanced or advanced metastatic gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) admitted to the study centers between January 1, 2014 and December 31, 2019.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
observation group
huachansu oral preparation (tablet, capsule) was used.
control group
huachansu was not used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 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
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
AE;SAE
Time Frame: 1 year, year 1
adverse event;Serious Adverse Event
1 year, year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADR;SADR
Time Frame: 1 year, year 1
Adverse Drug Reaction;Serious Adverse Drug Reaction
1 year, year 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 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
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
ORR
Time Frame: through study completion
ORR=CR+PR
through study completion
DCR
Time Frame: through study completion
DCR=CR+PR+SD
through study completion
BMI
Time Frame: through study completion
BMI=weight（kg）/height²（m²）
through study completion
Use of painkillers during treatment
Time Frame: through study completion
Proportion of patients using painkillers during treatment
through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2021

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ANTICIPATED)

February 28, 2022

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (ACTUAL)

February 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-HCS-CR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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