The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
310
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.
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.
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGXiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGWangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
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.
Time frame: The day of surgery until the first year
Disease-free survival
It is the time from randomization to tumor progression or death (from any cause).
Time frame: 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).
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
Refers to the proportion of patients with recurrence and metastasis within 1-3 years from the day of surgery.
Time frame: 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.
Time frame: 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.
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).
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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).
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
CEA
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
SCC
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
CYFR21-1
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
CA199
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
The ratio of lymphocytes to monocytes (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
The ratio of Lymphocyte to neutrophil ratio (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
Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 \^ 9 /L)
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)
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.
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)
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.
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
The number of cases and percentage were calculated as \< 80%, 80-120% and \> 120%
Time frame: 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.
Time frame: aseline until disease progression, death, or assessed up to 36 months after surgery.