Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study
1 other identifier
interventional
212
1 country
6
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2022
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedNovember 2, 2022
October 1, 2022
1.4 years
January 15, 2022
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (13)
Disease-free survival
Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
Overall survival
Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
Cumulative annual recurrence and metastasis rate for 1-3 years
The day of surgery until the once, second and third year.
Cumulative annual survival rate for 1-3 years
The day of surgery until the once, second and third year.
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).
- +8 more secondary outcomes
Study Arms (2)
Yiqi Wenyang Jiedu prescription Group
EXPERIMENTALSimulation agent of Yiqi Wenyang Jiedu prescription Group
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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;
- ECOG score 0-2;
- years old, male or female;
- The expected survival time is ≥3 months;
- Voluntary participation in the study, signing informed consent, good compliance with follow-up.
You may not qualify if:
- Patients with other primary tumors;
- 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;
- Patients who had previously received preoperative neoadjuvant chemotherapy;
- Patients with past or current targeted drug therapy;
- Patients undergoing previous or ongoing gastric radiotherapy;
- Patients with past or ongoing tumor immunotherapy;
- Mental patients;
- Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;
- Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months;
- Patients who are known to be allergic or intolerant to the study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jie Lilead
Study Sites (6)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091, China
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100102, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405, China
Jiangsu Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210004, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437, China
Related Publications (1)
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.
PMID: 39035732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Dean
Study Record Dates
First Submitted
January 15, 2022
First Posted
February 8, 2022
Study Start
March 1, 2022
Primary Completion
July 31, 2023
Study Completion
July 31, 2024
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.