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

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Gastric Adenocarcinoma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Outcomes

Primary Outcomes

overall survival

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

AE;SAE

adverse event;Serious Adverse Event

Time frame: 1 year, year 1

Secondary Outcomes

ADR;SADR

Adverse Drug Reaction;Serious Adverse Drug Reaction

Time frame: 1 year, year 1

Data from ClinicalTrials.gov

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