Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Neoplasm Metastasis

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Simulation agent of Qizhu Yuling Prescription Group

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.

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.

Placebo

Bowen Xu, Doctor

Jie Li, Professor

Guowang Yang, Professor

Yu Wu, Professor

Shijie Zhu, Professor

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.

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

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.

Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 1 years after surgery.

It is the time from randomization to tumor progression or death (from any cause).

It is the time from randomization to death (from any cause).

Refers to the proportion of patients with recurrence and metastasis within 1-3 years from the day of surgery.

Refers to the proportion of patients with survical within 1-3 years from the day of surgery.

Total Fat Area, Visceral Fat Area and Subcutaneous Fat Area. They measure fat area on cross-sectional images using plain CT scanning.

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).

The ratio of lymphocytes to monocytes (LMR)

The ratio of Lymphocyte to neutrophil ratio (LNR)

Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 \^ 9 /L)

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.

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.

The number of cases and percentage were calculated as \< 80%, 80-120% and \> 120%

Percentage of Participants With Adverse Events in different arms.

Spots Global Cancer Trial Database for qizhu yuling prescription