Gastric Adenocarcinoma
Conditions
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.
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.
Interventions
None listed
Sponsors
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| AE;SAE | 1 year, year 1 | adverse event;Serious Adverse Event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADR;SADR | 1 year, year 1 | Adverse Drug Reaction;Serious Adverse Drug Reaction |
Other
| Measure | Time frame | Description |
|---|---|---|
| BMI | through study completion | BMI=weight（kg）/height²（m²） |
| ORR | through study completion | ORR=CR+PR |
| Use of painkillers during treatment | through study completion | Proportion of patients using painkillers during treatment |
| DCR | through study completion | DCR=CR+PR+SD |
| 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 |
Countries
China
Outcome results
None listed