Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Yiqi Wenyang Jiedu prescription Group
|
Drug: Yiqi Wenyang Jiedu prescription
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.
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| Placebo Comparator: Simulation agent of Yiqi Wenyang Jiedu prescription Group
|
Drug: Simulation agent of Yiqi Wenyang Jiedu prescription
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
- 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).
- 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.
- 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.
- 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.
- 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).
- 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
- 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)
- 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)
- 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.
- 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%
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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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;
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ECOG score 0-2;
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18-75 years old, male or female;
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The expected survival time is ≥3 months;
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Voluntary participation in the study, signing informed consent, good compliance with follow-up.
Exclusion Criteria:
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Patients with other primary tumors;
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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;
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Patients who had previously received preoperative neoadjuvant chemotherapy;
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Patients with past or current targeted drug therapy;
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Patients undergoing previous or ongoing gastric radiotherapy;
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Patients with past or ongoing tumor immunotherapy;
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Mental patients;
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Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;
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Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months;
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Patients who are known to be allergic or intolerant to the study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing | China | 100021 |
| 2 | Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | Beijing | China | 100091 |
| 3 | Wangjing Hospital, China Academy of Chinese Medical Sciences | Beijing | Beijing | China | 100102 |
| 4 | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | China | 510405 |
| 5 | Jiangsu Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu | China | 210004 |
| 6 | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai | China | 200437 |
Sponsors and Collaborators
- Jie Li
Investigators
- Study Director: Jie Li, Professor, Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
- Principal Investigator: Yu Wu, Professor, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CI2021A01802