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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 Protocol for a multicenter, randomized, double-blind, placebo-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 Protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039038
Enrollment
Unknown
Registered
2020-10-14
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

gastric cancer

Interventions

Sponsors

Department of Oncology, Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Pathological diagnosis meets the diagnostic criteria for GC, and TCM syndrome differentiation is weakness of spleen and stomach; (2) Pathologically confirmed stage III and has implemented radical surgery; (3) ECOG score <= 2, aged 18 to 75 years; (4) Estimated survival time is more than 6 months; (5) Patients are volunteer and has signed informed consents. The process of obtaining an informed consent complies with the GCP requirements.

Exclusion criteria

Exclusion criteria: (1) Patients with metastatic gastric cancer; (2) Local recurrence or distant metastasis has been confirmed by histopathological or imaging examination; (3) Women during pregnancy and lactation; (4) Patients with severe primary cardiovascular, liver, renal or hematological disease; (5) Patients with serious primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival; (6) Disabled patients (blind, deaf, dumb, mentally, mentally or physically disabled) as prescribed by law; (7) Suspected or existing history of alcohol or drug abuse; (8) Other lesions that may reduce the possibility of enrollment or complicate the enrollment according to the judgment of the researcher, such as frequent changes of the work environment, that may easily lead to loss of follow-up; (9) Allergic constitution, such as two or more drugs or food allergies; Or known to be allergic to the ingredients of YQHYJD decoction ; (10) Patients who are participating in clinical studies of other drugs.

Design outcomes

Primary

MeasureTime frame
disease-free survival;progression-free survival rate at 1, 2 and 3 years;

Secondary

MeasureTime frame
Tumor markers;TCM syndrome scores;Quality of life score;Overall chemotherapy completion rate;Detection of intestinal flora diversity;Detection of immune function (T, B lymphocyte subsets, NK cells);

Countries

China

Contacts

Public ContactPeng Shu

Department of Oncology, Jiangsu Province Hospital of Chinese Medicine

shupengsp@163.com+86 13851701678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026