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

Study Overview

• Status: Recruiting
• Conditions: Esophagus Cancer
• Intervention / Treatment: Drug: Qizhu Yuling Prescription; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bowen Xu, Doctor; Phone Number: +86 18811732383; Email: 820850155@qq.com
• Study Contact Backup: Name: Jie Li, Professor; Phone Number: +86 010-88001711; Email: drjieli2007@126.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Qizhu Yuling Prescription	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 Comparator: Placebo Comparator; Simulation agent of Qizhu Yuling Prescription Group	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.; Other Names: Simulation agent of Qizhu Yuling Prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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).
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).
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).
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）.
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).
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).
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).
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).
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).
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).
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.
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.
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.

Collaborators and Investigators

• Sponsor: Jie Li
• Investigators: Study Director: Jie Li, Professor, Guang 'anmen Hospital, China Academy of Chinese Medical Sciences; Principal Investigator: Yu Wu, Professor, Xiyuan Hospital of China Academy of Chinese Medical Sciences; Principal Investigator: Shijie Zhu, Professor, Wangjing Hospital, China Academy of Chinese Medical Sciences; Principal Investigator: Guowang Yang, Professor, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 19, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 19, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Chinese Herbal Medicine; Randomized Controlled Trial; Postoperative esophagus cancer; Qizhu Yuling prescription; 1-year disease-free survival rate
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 2022-1-4151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No