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

Jie Li

Status and phase: Enrolling; Phase 4

Conditions: Gastric Carcinoma

Treatments: Drug: Yiqi Wenyang Jiedu prescription; Drug: Simulation agent of Yiqi Wenyang Jiedu prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT05229809

CI2021A01802

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.

Full 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 randomly divided into experimental (n=106) and control groups (n=106).Patients in the experimental group was treated with Yiqiuyang Jiedu prescription within 6-8 months after radical gastroctomy and after the completion of standard regimen (XELOX and SOX) for at least 6 cycles of adjuvant chemotherapy. Patients in the control group will receive the placebo.The primary endpoint is 2-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 2 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Enrollment: 212 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups, including a placebo group

Yiqi Wenyang Jiedu prescription Group

Experimental group

Treatment:

Drug: Yiqi Wenyang Jiedu prescription

Simulation agent of Yiqi Wenyang Jiedu prescription Group

Placebo Comparator group

Treatment:

Drug: Simulation agent of Yiqi Wenyang Jiedu prescription