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A clinical study on the efficacy of Yiqi Huayu Jiedu decoction for reducing the risk of postoperative recurrence and metastasis of gastric cancer by regulating immune cells: Protocol for a randomized controlled trial

A clinical study on the efficacy of Yiqi Huayu Jiedu decoction for reducing the risk of postoperative recurrence and metastasis of gastric cancer by regulating immune cells: Protocol for a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000899
Enrollment
Unknown
Registered
2025-05-07
Start date
2021-05-13
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Treatment Group:chemotherapy+TCM
Control Group:chemotherapy

Sponsors

Department of Oncology Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The pathological diagnosis was in line with the diagnostic criteria for gastric cancer and the syndrome differentiation of TCM was weakness of the spleen and stomach; (2) Patients with pathological stage III who have undergone radical surgery; (3) ECOG score =2 points aged between 18-75 years old; (4) The expected survival time is more than 6 months; (5) Sign informed consent. Volunteer to take the test. The process of obtaining informed consent shall comply with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) Patients with metastatic gastric cancer; (2) Local recurrence or distant metastasis has been confirmed by histopathology or imaging examination; (3) pregnant and lactating women; (4) severe primary cardiovascular disease liver disease kidney disease hematological disease; (5) have serious primary heart liver lung kidney blood or serious diseases affecting their survival; (6) Persons with disabilities defined by law (blind deaf mute mentally handicapped mentally handicapped physically handicapped); (7) Suspected or have a history of alcohol and drug abuse; (8) Other diseases that reduce the possibility of enrollment or complicate enrollment such as frequent changes in the working environment are likely to cause loss of follow-up according to the judgment of the investigator; (9) allergies such as allergies to two or more drugs or food; Or known allergy to the ingredients of the drug; (10) Patients who are participating in clinical studies of other drugs.

Design outcomes

Primary

MeasureTime frame
1-year and 2-year progression-free survival rates;Cytokine detection;Cell immune function test;DFS;

Secondary

MeasureTime frame
Overall chemotherapy completion rate;TCM syndrome integral;tumor biomarker;Quality of life score;

Countries

China

Contacts

Public ContactCunen Wu

Jiangsu Province Hospital of Chinese Medicine

714494480@qq.com+86 15651660263

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026