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

• Conditions: Gastric Adenocarcinoma

• Registration Number: NCT05249244
• Lead Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2021-12-31
• Study First Submitted: 2022-01-20
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ADR;SADR	1 year, year 1	Adverse Drug Reaction;Serious Adverse Drug Reaction

Trial Locations

Locations (1)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, China