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

Esophagus Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626309
• Other study ID #: 2022-1-4151
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Bowen Xu, Doctor
• Phone: +86 18811732383
• Email: 820850155[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: November 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Hospital of Traditional Chinese Medicine, Capital Medical University	Beijing	Beijing
China	Wangjing Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jie Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease-free survival	It is the time from randomization to tumor progression or death (from any cause).	Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
Secondary	Overall survival	It is the time from randomization to death (from any cause).	Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
Secondary	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.	The day of surgery until the once, second and third year.
Secondary	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.	The day of surgery until the once, second and third year.
Secondary	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.	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).
Secondary	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).	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).
Secondary	Tumor marker	CEA	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).
Secondary	Tumor marker	SCC	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).
Secondary	Tumor marker	CYFR21-1	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).
Secondary	Tumor marker	CA199	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).
Secondary	Peripheral blood inflammatory index LMR	The ratio of lymphocytes to monocytes (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).
Secondary	Peripheral blood inflammatory index LNR	The ratio of Lymphocyte to neutrophil ratio (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).
Secondary	Prognostic nutritional index	Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 ^ 9 /L)	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).
Secondary	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.	Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Secondary	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.	Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
Secondary	Medication compliance	The number of cases and percentage were calculated as < 80%, 80-120% and > 120%	From randomization to the end of the sixth course of medication (up to 24 weeks).
Secondary	Percentage of Participants With Adverse Events	Percentage of Participants With Adverse Events in different arms.	aseline until disease progression, death, or assessed up to 36 months after surgery.