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A multicenter randomized controlled clinical study on the prevention of postoperative recurrent metastasis of gastric cancer by Yiqi Wenyang Jiedu formula

A multicenter randomized controlled clinical study on the prevention of postoperative recurrent metastasis of gastric cancer by Yiqi Wenyang Jiedu formula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001471
Enrollment
Unknown
Registered
2025-07-21
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

gastric carcinoma

Interventions

Experimental group:Yiqi Wenyang Jiedu Formula Granules
Control group:Yiqi Wenyang Jiedu Formula Granular Simulation Agent

Sponsors

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Non-esophagogastric junction stage I-III gastric cancer that meets the diagnostic criteria and is determined by imaging to have no tumor recurrence or metastasis; 2. Have completed gastric cancer resection and have no plans for adjuvant therapy or have completed adjuvant therapy; 3.ECOG score: 0-2 points; 4.18-75 years old gender not limited; 5. The expected survival period is =3 months; 6. Voluntarily join the study sign the informed consent form have good compliance and cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Those with primary tumors in other parts; 2. Mentally ill patients 3. Patients with severe and uncontrolled organic lesions or infections such as decompensated heart lung and kidney failure who cannot tolerate chemotherapy; 4. Patients who have received clinical trial treatment of small molecule drugs within 28 days or clinical trial treatment of large molecule drugs within 3 months; 5. Patients who are known to be allergic or intolerant to the investigational drug.

Design outcomes

Primary

MeasureTime frame
the DFS rate within 2 years after the operation;

Secondary

MeasureTime frame
The median time of OS;Symptom and quality of life evaluation;Tumor marker;Median time of DFS;Life function status;NLR;

Countries

China

Contacts

Public ContactDaorui Li

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

lidaorui@sina.com13691495064

Outcome results

None listed

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