Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer

NCT ID: NCT05626309

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-11-30

Brief 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.

Conditions

Esophagus Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Qizhu Yuling Prescription

Qizhu Yuling Prescription

Group Type: EXPERIMENTAL

Qizhu Yuling Prescription

Intervention Type: DRUG

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.

Placebo Comparator

Simulation agent of Qizhu Yuling Prescription Group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Qizhu Yuling 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 esophageal cancer surgery.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Simulation agent of Qizhu Yuling Prescription

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jie Li

OTHER

Sponsor Role: lead

Responsible Party

Jie Li

Vice President

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

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

Guowang Yang, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital of Traditional Chinese Medicine

Locations

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Wangjing Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bowen Xu, Doctor

Role: CONTACT

820850155@qq.com

+86 18811732383

Jie Li, Professor

Role: CONTACT

drjieli2007@126.com

+86 010-88001711

Facility Contacts

Guowang Yang, Professor

Role: primary

Yu Wu, Professor

Role: primary

Shijie Zhu, Professor

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40206581 (View on PubMed)

Other Identifiers

2022-1-4151

Identifier Type: -

Identifier Source: org_study_id