Overview

Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer

Status:
Not yet recruiting
Trial end date:
2024-07-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jie Li
Criteria
Inclusion Criteria:

- 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; ③ECOG score 0-2; ④18-75 years old, male or female; ⑤The expected
survival time is ≥3 months; ⑥Voluntary participation in the study, signing
informed consent, good compliance with follow-up.

Exclusion Criteria:

- 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; ⑥
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; 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.