Clinical trial · Interventional
Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer:A Randomized, Double-blind, Controlled and Multi-center Clinical Study
NCT05229809CI-TRIAL-00061906unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simulation agent of Yiqi Wenyang Jiedu prescription | Drug | — | UNRESOLVED |
| Yiqi Wenyang Jiedu prescription | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Yiqi Wenyang Jiedu prescription Group
- interventionNames
- Drug: Yiqi Wenyang Jiedu prescription
- type
- PLACEBO_COMPARATOR
- label
- Simulation agent of Yiqi Wenyang Jiedu prescription Group
- interventionNames
- Drug: Simulation agent of Yiqi Wenyang Jiedu prescription
Primary outcomes (1)
- measure
- 2-year disease-free survival rate
- timeFrame
- The day of surgery until the second year.
- description
- Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 2 years after surgery.
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The non-esophagogastric junction gastric cancer of stage II-III that met the diagnostic criteria, and no tumor recurrence and metastasis was determined by imaging; 2. Within 6-8 months after radical gastrectomy for gastric cancer (R0), adjuvant chemotherapy of standard regimen (XELOX and SOX) has been completed for at least 6 cycles; 3. ECOG score 0-2; 4. 18-75 years old, male or female; 5. The expected survival time is ≥3 months; 6. Voluntary participation in the study, signing informed consent, good compliance with follow-up. Exclusion Criteria: 1. Patients with other primary tumors; 2. Gastric cancer patients were pathologically diagnosed as adenosquamous carcinoma, with lymphoid stromal carcinoma (medullary carcinoma), hepatoid adenocarcinoma, squamous cell carcinoma, signed-ring cell carcinoma, undifferentiated carcinoma, gastric neuroendocrine tumor, gastric mesenchymal tumor, gastric malignant lymphoma and other gastric malignancies; 3. Patients who had previously received preoperative neoadjuvant chemotherapy; 4. Patients with past or current targeted drug therapy; 5. Patients undergoing previous or ongoing gastric radiotherapy; 6. Patients with past or ongoing tumor immunotherapy; 7. Mental patients; 8. Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy; 9. Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months; 10. Patients who are known to be allergic or intolerant to the study drug.
References
Publications (1)
- DERIVEDCao L, Zhu G, Wang X, Kuang Z, Song X, Ma X, Zhu X, Gao R, Li J. Yiqi Wenyang Jiedu prescription for preventing and treating postoperative recurrence and metastasis of gastric cancer: a randomized controlled trial protocol. Front Oncol. 2024 Jul 5;14:1326970. doi: 10.3389/fonc.2024.1326970. eCollection 2024. PMID 39035732