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

Sponsors

Lead Sponsor: Jie Li

Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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.

Overall Status Recruiting
Start Date 2022-10-01
Completion Date 2024-11-30
Primary Completion Date 2024-08-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
1-year disease-free survival rate The day of surgery until the first year
Secondary Outcome
Measure Time Frame
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).
Visceral Adiposity Index 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 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 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 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 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 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 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 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) 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) Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Medication compliance From randomization to the end of the sixth course of medication (up to 24 weeks).
Percentage of Participants With Adverse Events aseline until disease progression, death, or assessed up to 36 months after surgery.
Enrollment 310
Condition
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

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

Overall Official
Overall Contact

Last Name: Bowen Xu, Doctor

Phone: +86 18811732383

Email: [email protected]

Location
Facility: Status: Contact:
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University | Beijing, Beijing, 100010, China Recruiting Guowang Yang, Professor
Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing, Beijing, 100091, China Recruiting Yu Wu, Professor
Wangjing Hospital, China Academy of Chinese Medical Sciences | Beijing, Beijing, 100102, China Recruiting Shijie Zhu, Professor
Location Countries

China

Verification Date

2022-11-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigator Full Name: Jie Li

Investigator Title: Vice President

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Qizhu Yuling Prescription

Type: Experimental

Description: Qizhu Yuling Prescription

Label: Placebo Comparator

Type: Placebo Comparator

Description: Simulation agent of Qizhu Yuling Prescription Group

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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