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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observation group | huachansu oral preparation (tablet, capsule) was used. | ||
| control group | huachansu was not used. |
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| Measure | Description | Time Frame |
|---|---|---|
| OS | 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 | adverse event;Serious Adverse Event | 1 year, year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| ADR;SADR | Adverse Drug Reaction;Serious Adverse Drug Reaction | 1 year, year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR=CR+PR | through study completion |
| DCR | DCR=CR+PR+SD | through study completion |
Inclusion Criteria:
Only patients who meet all the following criteria are included in the study:
Exclusion Criteria:
Patients who meet any of the following criteria are not allowed to enter the test:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| kangsheng gu | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | China |
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| PFS | 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 |
| BMI | BMI=weight(kg)/height²(m²) | through study completion |
| Use of painkillers during treatment | Proportion of patients using painkillers during treatment | through study completion |