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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yiqi Wenyang Jiedu prescription Group | Experimental |
| |
| Simulation agent of Yiqi Wenyang Jiedu prescription Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yiqi Wenyang Jiedu prescription | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The day of surgery until the second year. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | It is the time from randomization to tumor progression or death (from any cause). | Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first. |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guanghui Zhu, Doctor | Contact | +86 13315714979 | zhugh0822@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Li, Professor | Guang 'anmen Hospital, China Academy of Chinese Medical Sciences | Study Director |
| Yu Wu, Professor | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39035732 | Derived | Cao L, Zhu G, Wang X, Kuang Z, Song X, Ma X, Zhu X, Gao R, Li J. Yiqi Wenyang Jiedu prescription for preventing and treating postoperative recurrence and metastasis of gastric cancer: a randomized controlled trial protocol. Front Oncol. 2024 Jul 5;14:1326970. doi: 10.3389/fonc.2024.1326970. eCollection 2024. |
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The results of the study will be issued to publications through scientific journals and conference reports. The anonymized datasets used and/or analyzed during the current study are available from the sponsor-investigator on reasonable request.
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| Simulation agent of Yiqi Wenyang Jiedu prescription | Drug | 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. |
|
It is the time from randomization to death (from any cause). |
| 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. | 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. | 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. | 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). |
| Visceral 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). | 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 | 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) | 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) | 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. | 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. | 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% | 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. | Baseline until disease progression, death, or assessed up to 36 months after surgery. |
| Shijie Zhu, Professor | Wangjing Hospital, China Academy of Chinese Medical Sciences | Principal Investigator |
| Hong Zhao, Professor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Lizhu Lin, Professor | The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | Principal Investigator |
| Ling Xu, Professor | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine | Principal Investigator |
| Peng Shu, Professor | Jiangsu Hospital of Traditional Chinese Medicine | Principal Investigator |
| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100091 | China |
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| Wangjing Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100102 | China |
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| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510405 | China |
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| Jiangsu Hospital of Traditional Chinese Medicine | Recruiting | Nanjing | Jiangsu | 210004 | China |
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| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 200437 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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