Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
NCT ID: NCT05229809
Last Updated: 2022-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
212 participants
INTERVENTIONAL
2022-03-01
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Yiqi Wenyang Jiedu prescription Group
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.
Simulation agent of Yiqi Wenyang Jiedu prescription Group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jie Li
OTHER
Responsible Party
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Jie Li
Assistant Dean
Principal Investigators
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Jie Li, Professor
Role: STUDY_DIRECTOR
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Yu Wu, Professor
Role: PRINCIPAL_INVESTIGATOR
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Shijie Zhu, Professor
Role: PRINCIPAL_INVESTIGATOR
Wangjing Hospital, China Academy of Chinese Medical Sciences
Hong Zhao, Professor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lizhu Lin, Professor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Ling Xu, Professor
Role: PRINCIPAL_INVESTIGATOR
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Peng Shu, Professor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Hospital of Traditional Chinese Medicine
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Jiangsu Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hong Zhao
Role: primary
Yu Wu
Role: primary
Shijie Zhu
Role: primary
Lizhu Lin
Role: primary
Peng Shu
Role: primary
Ling Xu
Role: primary
References
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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.
Other Identifiers
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CI2021A01802
Identifier Type: -
Identifier Source: org_study_id
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