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

Phase 4

Recruiting

• Conditions: Gastric Carcinoma
• Interventions: Drug: Simulation agent of Yiqi Wenyang Jiedu prescription; Drug: Yiqi Wenyang Jiedu prescription

• Registration Number: NCT05229809
• Lead Sponsor: Jie Li

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 Timeline

• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-08
• Study Start: 2022-03-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simulation agent of Yiqi Wenyang Jiedu prescription Group	Simulation agent of Yiqi Wenyang Jiedu prescription	-
Yiqi Wenyang Jiedu prescription Group	Yiqi Wenyang Jiedu prescription	-

Primary Outcome Measures

Name	Time	Method
2-year disease-free survival rate	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 Outcome Measures

Name	Time	Method
Overall survival	Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.	It is the time from randomization to death (from any cause).
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).	Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 \^ 9 /L)
Disease-free survival	Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.	It is the time from randomization to tumor progression or death (from any cause).
Cumulative annual recurrence and metastasis rate for 1-3 years	The day of surgery until the once, second and third year.	Refers to the proportion of patients with recurrence and metastasis within 1-3 years from the day of surgery.
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).	It is a new assessment of visceral fat based on waist circumference (WC), BMI, triglyceride (TG) and HDL.; Male VAI = during \[WC/(39.68 + 1.88 x BMI)\] \* (TG / 1.03) \* (1.31 / HDL). Female VAI = during \[WC/(36.58 + 1.89 x BMI)\] \* (TG / 0.81) \* (1.52 / HDL).
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).	The ratio of lymphocytes to monocytes (LMR) and ratio of Lymphocyte to neutrophil ratio (LNR)
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.	This will be measured with M. D. Anderson Symptom Inventory (MDASI-GI) and Postgastrectomy Syndrome Assessment Scale (PGSAS-45). The minimum score of MDASI-GI is 0 and the maximum is 240. The minimum score of PGSAS-45 is 0 and the maximum is 271. A higher score indicates a poorer symptom.
Medication compliance	From randomization to the end of the sixth course of medication （up to 24 weeks）.	The number of cases and percentage were calculated as \< 80%, 80-120% and \> 120%
Cumulative annual survival rate for 1-3 years	The day of surgery until the once, second and third year.	Refers to the proportion of patients with survical within 1-3 years from the day of surgery.
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.	This will be measured with Quality of Life Questionnaire of Stomach22 (QLQ-STO22). The minimum score is 22 and the maximum is 88. A higher score indicates a poorer quality of life.
Percentage of Participants With Adverse Events	Baseline until disease progression, death, or assessed up to 36 months after surgery.	Percentage of Participants With Adverse Events in different arms.
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).	Total Fat Area, Visceral Fat Area and Subcutaneous Fat Area. They measure fat area on cross-sectional images using plain CT scanning.
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).	CEA, CA724 and CA199

Trial Locations

Locations (6)

Xiyuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Wangjing Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Jiangsu Hospital of Traditional Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China