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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 212
- Locations
- 6
- Primary Endpoint
- 2-year disease-free survival rate
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •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 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;
- •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.
Arms & Interventions
Yiqi Wenyang Jiedu prescription Group
Intervention: Yiqi Wenyang Jiedu prescription (Drug)
Simulation agent of Yiqi Wenyang Jiedu prescription Group
Intervention: Simulation agent of Yiqi Wenyang Jiedu prescription (Drug)
Outcomes
Primary Outcomes
2-year disease-free survival rate
Time Frame: The day of surgery until the second year.
Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 2 years after surgery.
Secondary Outcomes
- Overall survival(Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.)
- Prognostic nutritional index(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Medication compliance(From randomization to the end of the sixth course of medication （up to 24 weeks）.)
- Disease-free survival(Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.)
- Cumulative annual recurrence and metastasis rate for 1-3 years(The day of surgery until the once, second and third year.)
- Visceral Adiposity Index(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Peripheral blood inflammatory index(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Evaluation of the patient's symptoms(Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.)
- Cumulative annual survival rate for 1-3 years(The day of surgery until the once, second and third year.)
- Quality of life of the patient(Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.)
- Percentage of Participants With Adverse Events(Baseline until disease progression, death, or assessed up to 36 months after surgery.)
- Indexes related to fat distribution(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Tumor marker(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
Investigators
Jie Li
Assistant Dean
Guang'anmen Hospital of China Academy of Chinese Medical Sciences