Status:
UNKNOWN
Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
Lead Sponsor:
Jie Li
Conditions:
Gastric Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Detailed Description
This study include a multicenter, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 212 patients. Participants will be rando...
Eligibility Criteria
Inclusion
- 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;
- 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;
- ECOG score 0-2;
- 18-75 years old, male or female;
- The expected survival time is ≥3 months;
- Voluntary participation in the study, signing informed consent, good compliance with follow-up.
Exclusion
- Patients with other primary tumors;
- 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;
- Patients who had previously received preoperative neoadjuvant chemotherapy;
- Patients with past or current targeted drug therapy;
- Patients undergoing previous or ongoing gastric radiotherapy;
- Patients with past or ongoing tumor immunotherapy;
- Mental patients;
- Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;
- Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months;
- Patients who are known to be allergic or intolerant to the study drug.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05229809
Start Date
March 1 2022
End Date
July 31 2024
Last Update
November 2 2022
Active Locations (6)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100091
3
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100102
4
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405