Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer
Qizhu Yuling Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Esophagus Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study
1 other identifier
interventional
310
1 country
3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 31, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedNovember 23, 2022
November 1, 2022
1.9 years
October 31, 2022
November 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-year disease-free survival rate
Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 1 years after surgery.
The day of surgery until the first year
Secondary Outcomes (17)
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).
- +12 more secondary outcomes
Study Arms (2)
Qizhu Yuling Prescription
EXPERIMENTALQizhu Yuling Prescription
Placebo Comparator
PLACEBO COMPARATORSimulation agent of Qizhu Yuling Prescription Group
Interventions
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 esophageal 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 esophageal cancer surgery.
Eligibility Criteria
You may qualify if:
- \. Esophageal cancer without esophagogastric junction pT1-4aN + M0 (stage IIB-IVA) meeting the diagnostic criteria without recurrence or metastasis;
- \. Patients who have completed adjuvant therapy (including adjuvant radiotherapy, adjuvant chemotherapy, adjuvant chemotherapy + radiotherapy) within 6 months after R0 resection for esophageal cancer;
- \. ECOG score 0-2;
- \. 18-75 years old;
- \. Expected survival ≥ 3 months;
- \. Subjects voluntarily signed informed consent.
You may not qualify if:
- \. Combined with primary tumor at other sites;
- \. Patients complicated with severe primary diseases of heart, cerebral vessels, liver, kidney and hematopoietic system;
- \. Patients with mental illness and mental and language disorders;
- \. Participation in other clinical trials within 3 months;
- \. Patients with known hypersensitivity or intolerance to study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jie Lilead
Study Sites (3)
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, 100010, 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
Related Publications (1)
Kong M, Xu B, Zhu G, Wang X, Kuang Z, Sun Q, Liu K, Wang Z, Zhang Y, Li J. Qizhu Yuling prescription in the prevention of postoperative metastasis and recurrence of esophagus cancer: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial. Front Oncol. 2025 Mar 26;15:1478390. doi: 10.3389/fonc.2025.1478390. eCollection 2025.
PMID: 40206581DERIVED
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
Guowang Yang, Professor
Beijing Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice President
Study Record Dates
First Submitted
October 31, 2022
First Posted
November 23, 2022
Study Start
October 1, 2022
Primary Completion
August 30, 2024
Study Completion
November 30, 2024
Last Updated
November 23, 2022
Record last verified: 2022-11
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.