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

NCT05249244 | Unknown

• 1 other identifier: ICM-HCS-CR01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• ADR;SADR

  1 year, year 1

Other Outcomes (5)

• ORR

  through study completion

• DCR

  through study completion

• 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

Study Arms (2)

observation group

huachansu oral preparation (tablet, capsule) was used.

control group

huachansu was not used.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Only patients who meet all the following criteria are included in the study:
• 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.
• Stage of disease (clinical or pathological stage) is locally advanced or advanced (stage IIIB-IV) .
• The doctor judged that the tumor tissue was unresectable.
• At least two medical records.
• At least one huachansu oral preparation (tablet, capsule) was used during treatment (observation group only) .

You may not qualify if:

• Patients who meet any of the following criteria are not allowed to enter the test:
• Lack of clinical data related to important research indicators (survival).
• Refusal to cooperate with follow-up.

Sponsors & Collaborators

• China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Study Officials

• kangsheng gu

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 21, 2022
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)