To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer
NCT ID:
NCT05626309
Condition:
Esophagus Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Postoperative esophagus cancer
Qizhu Yuling prescription
Chinese Herbal Medicine
Randomized Controlled Trial
1-year disease-free survival rate
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Qizhu Yuling Prescription
Description:
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.
Arm group label:
Qizhu Yuling Prescription
Intervention type:
Drug
Intervention name:
Placebo
Description:
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.
Arm group label:
Placebo Comparator
Other name:
Simulation agent of Qizhu Yuling Prescription
Summary:
The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling
prescription for postoperative esophagus cancer.
Detailed description:
This study include a multi-center, randomized, double-blind, placebo, parallel controlled
clinical trial.The randomized clinical trial will enroll approximately 310 patients.
Participants will be randomly divided into experimental (n=155) and placebo groups
(n=155).Patients in the experimental group was treated with Qizhu Yuling prescription
within 6 months after esophagus cancer R0. Patients in the control group will receive the
placebo.The primary endpoint is 1-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 1 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Esophageal cancer without esophagogastric junction pT1-4aN + M0 (stage IIB-IVA)
meeting the diagnostic criteria without recurrence or metastasis;
2. Patients who have completed adjuvant therapy (including adjuvant radiotherapy,
adjuvant chemotherapy, adjuvant chemotherapy + radiotherapy) within 6 months
after R0 resection for esophageal cancer;
3. ECOG score 0-2;
4. 18-75 years old;
5. Expected survival ≥ 3 months;
6. Subjects voluntarily signed informed consent.
Exclusion Criteria:
-
1. Combined with primary tumor at other sites;
2. Patients complicated with severe primary diseases of heart, cerebral vessels,
liver, kidney and hematopoietic system;
3. Patients with mental illness and mental and language disorders;
4. Participation in other clinical trials within 3 months;
5. Patients with known hypersensitivity or intolerance to study drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Contact:
Last name:
Guowang Yang, Professor
Facility:
Name:
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Address:
City:
Beijing
Zip:
100091
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Wu, Professor
Facility:
Name:
Wangjing Hospital, China Academy of Chinese Medical Sciences
Address:
City:
Beijing
Zip:
100102
Country:
China
Status:
Recruiting
Contact:
Last name:
Shijie Zhu, Professor
Start date:
October 1, 2022
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Jie Li
Agency class:
Other
Source:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05626309
