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

Gastric Adenocarcinoma Clinical Trial

Official title:

A Real World Study of the Treatment of Locally-inoperable Advanced or Advanced Metastatic Gastric Adenocarcinoma With Huachansu

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05249244
• Other study ID #: ICM-HCS-CR01
• Status: Active, not recruiting
• Start date: July 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2022
• Source: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Anhui Medical University	Hefei

Sponsors (1)

Lead Sponsor	Collaborator
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ORR	ORR=CR+PR	through study completion
Other	DCR	DCR=CR+PR+SD	through study completion
Other	PFS	progression-free 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
Other	BMI	BMI=weight(kg)/height²(m²)	through study completion
Other	Use of painkillers during treatment	Proportion of patients using painkillers during treatment	through study completion
Primary	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
Primary	AE;SAE	adverse event;Serious Adverse Event	1 year, year 1
Secondary	ADR;SADR	Adverse Drug Reaction;Serious Adverse Drug Reaction	1 year, year 1