Clinical trial NCT05249244: A Real World Study of the Treatment of Gastric Adenocarcinoma With Huachansu
Official title: A Real World Study of the Treatment of Locally-inoperable Advanced or Advanced Metastatic Gastric Adenocarcinoma With Huachansu
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Adenocarcinoma
Lead sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: OS
timeFrame: 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
measure: AE;SAE
timeFrame: 1 year, year 1
Secondary outcomes:
measure: ADR;SADR
timeFrame: 1 year, year 1
Other outcomes:
measure: ORR
timeFrame: through study completion
measure: DCR
timeFrame: through study completion
measure: PFS
timeFrame: 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
measure: BMI
timeFrame: through study completion
measure: Use of painkillers during treatment
timeFrame: through study completion
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: kangsheng gu
role: PRINCIPAL_INVESTIGATOR
References: