The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
The dosage form of the test drug is granule. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.
It is prepared from maltodextrin and food coloring. The raw materials of maltodextrin conform to the relevant provisions of excipients - maltodextrin in the fourth part of Chinese Pharmacopoeia 2015 edition. Food coloring includes caramel coloring, egg yolk coloring and milk chocolate brown pigment, all of which are edible grade ingredients. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGXiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGWangjing Hospital, China Academy of Chinese Medical Sciences
2-year disease-free survival rate
Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 2 years after surgery.
Time frame: The day of surgery until the second year.
Disease-free survival
It is the time from randomization to tumor progression or death (from any cause).
Time frame: Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
Overall survival
It is the time from randomization to death (from any cause).
Time frame: Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
Cumulative annual recurrence and metastasis rate for 1-3 years
Refers to the proportion of patients with recurrence and metastasis within 1-3 years from the day of surgery.
Time frame: The day of surgery until the once, second and third year.
Cumulative annual survival rate for 1-3 years
Refers to the proportion of patients with survical within 1-3 years from the day of surgery.
Time frame: The day of surgery until the once, second and third year.
Indexes related to fat distribution
Total Fat Area, Visceral Fat Area and Subcutaneous Fat Area. They measure fat area on cross-sectional images using plain CT scanning.
Time frame: 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).
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Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGJiangsu Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
RECRUITINGYueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGVisceral Adiposity Index
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).
Time frame: 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
CEA, CA724 and CA199
Time frame: 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
The ratio of lymphocytes to monocytes (LMR) and ratio of Lymphocyte to neutrophil ratio (LNR)
Time frame: 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).
Prognostic nutritional index
Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 \^ 9 /L)
Time frame: 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).
Quality of life of the patient
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.
Time frame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Evaluation of the patient's symptoms
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.
Time frame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Medication compliance
The number of cases and percentage were calculated as \< 80%, 80-120% and \> 120%
Time frame: From randomization to the end of the sixth course of medication （up to 24 weeks）.
Percentage of Participants With Adverse Events
Percentage of Participants With Adverse Events in different arms.
Time frame: Baseline until disease progression, death, or assessed up to 36 months after surgery.