Esophagus CancerNCT05626309
Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer
A study testing Qizhu Yuling Prescription in people with Esophagus Cancer, run by Jie Li at 3 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Qizhu Yuling Prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, 100010
Guowang Yang, Professor
- Recruiting
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Yu Wu, Professor
- Recruiting
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100102
Shijie Zhu, Professor
About this study
Official title: 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
The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.
Read the 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.
- Conditions
- Esophagus Cancer
- Being tested
- Qizhu Yuling Prescription, Placebo
- Keywords
- Postoperative esophagus cancer, Qizhu Yuling prescription, Chinese Herbal Medicine, Randomized Controlled Trial, 1-year disease-free survival rate
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qizhu Yuling PrescriptionDrug
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.
PlaceboDrug
Also called Simulation agent of Qizhu Yuling 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 esophageal cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Qizhu Yuling Prescription | Experimental | Qizhu Yuling Prescription Receives: Drug: Qizhu Yuling Prescription |
| Placebo Comparator | Placebo comparator | Simulation agent of Qizhu Yuling Prescription Group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The day of surgery until the first year
Secondary outcomes (17)
Disease-free survival
It is the time from randomization to tumor progression or death (from any cause).
Measured: Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
Overall survival
It is the time from randomization to death (from any cause).
Measured: Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
Cumulative annual recurrence and metastasis rate for 1-3 years
Refers to the proportion of patients with recurrence and metastasis within 1-3 years from the day of surgery.
Measured: The day of surgery until the once, second and third year.
Cumulative annual survival rate for 1-3 years
Refers to the proportion of patients with survical within 1-3 years from the day of surgery.
Measured: The day of surgery until the once, second and third year.
Indexes related to fat distribution
Total Fat Area, Visceral Fat Area and Subcutaneous Fat Area. They measure fat area on cross-sectional images using plain CT scanning.
Measured: 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).
Visceral Adiposity Index
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).
Measured: 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).
Tumor marker
CEA
Measured: 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).
Tumor marker
SCC
Measured: 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).
Tumor marker
CYFR21-1
Measured: 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).
Tumor marker
CA199
Measured: 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).
Peripheral blood inflammatory index LMR
The ratio of lymphocytes to monocytes (LMR)
Measured: 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).
Peripheral blood inflammatory index LNR
The ratio of Lymphocyte to neutrophil ratio (LNR)
Measured: 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).
Prognostic nutritional index
Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 ^ 9 /L)
Measured: 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).
Quality of life of the patient (QLQ-QES18)
The score will be measured by Quality of Life Questionnaire of Oesophageal-Specific Module 18. Each question is scored from 1 to 4 with 18 questions giving a total score of 18 to 72. A higher score indicates a poorer quality of life.
Measured: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Evaluation of the patient's symptoms (MDASI-TCM)
The score will be measured with M. D. Anderson Symptom Traditional Chinese Medicine. Each question is scored from 0 to 10 with 26 questions for a total score of 0 to 260. A higher score indicates a poorer symptom.
Measured: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Medication compliance
The number of cases and percentage were calculated as < 80%, 80-120% and > 120%
Measured: From randomization to the end of the sixth course of medication （up to 24 weeks）.
Percentage of Participants With Adverse Events
Percentage of Participants With Adverse Events in different arms.
Measured: aseline until disease progression, death, or assessed up to 36 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Oct 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jie Li, Professor, Study director, Guang 'anmen Hospital, China Academy of Chinese Medical SciencesYu Wu, Professor, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical SciencesShijie Zhu, Professor, Principal investigator, Wangjing Hospital, China Academy of Chinese Medical SciencesGuowang Yang, Professor, Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626309
- Sponsor's protocol ID
- 2022-1-4151
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40206581
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05626309
- Acronym / sponsor ID
- 2022-1-4151
- Conditions
- Esophagus Cancer
- Keywords
- Postoperative esophagus cancer, Qizhu Yuling prescription, Chinese Herbal Medicine, Randomized Controlled Trial, 1-year disease-free survival rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Jie LiUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qizhu Yuling Prescription | Experimental | Drug: Qizhu Yuling PrescriptionQizhu Yuling Prescription |
| Placebo Comparator | Placebo comparator | Drug: PlaceboSimulation agent of Qizhu Yuling Prescription Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qizhu Yuling PrescriptionThe 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. | Drug | Qizhu Yuling Prescription |
| PlaceboAlso: Simulation agent of Qizhu Yuling PrescriptionIt 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. | Drug | Placebo Comparator |
Primary outcome
1-year disease-free survival rate
Time frame: The day of surgery until the first year
Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 1 years after surgery.
17 secondary outcomes
Disease-free survival
Time frame: Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
Overall survival
Time frame: Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
Cumulative annual recurrence and metastasis rate for 1-3 years
Time frame: The day of surgery until the once, second and third year.
Cumulative annual survival rate for 1-3 years
Time frame: The day of surgery until the once, second and third year.
Indexes related to fat distribution
Time frame: 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).
Visceral Adiposity Index
Time frame: 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).
Tumor marker
Time frame: 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).
Tumor marker
Time frame: 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).
Tumor marker
Time frame: 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).
Tumor marker
Time frame: 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).
Peripheral blood inflammatory index LMR
Time frame: 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).
Peripheral blood inflammatory index LNR
Time frame: 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).
Prognostic nutritional index
Time frame: 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).
Quality of life of the patient (QLQ-QES18)
Time frame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Evaluation of the patient's symptoms (MDASI-TCM)
Time frame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Medication compliance
Time frame: From randomization to the end of the sixth course of medication （up to 24 weeks）.
Percentage of Participants With Adverse Events
Time frame: aseline until disease progression, death, or assessed up to 36 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 40206581Kong 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Li, Professor study director
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Yu Wu, Professor principal investigator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Shijie Zhu, Professor principal investigator
Wangjing Hospital, China Academy of Chinese Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qizhu Yuling Prescription in people with Esophagus Cancer, run by Jie Li at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bowen Xu, Doctor (+86 18811732383, 820850155@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year disease-free survival rate (time frame: The day of surgery until the first year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.