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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 30, 2024

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Qizhu Yuling Prescription
    • Qizhu Yuling Prescription
  • Placebo Comparator: Placebo Comparator
    • Simulation agent of Qizhu Yuling Prescription Group

Clinical Trial Outcome Measures

Primary Measures

  • 1-year disease-free survival rate
    • Time Frame: The day of surgery until the first year
    • Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 1 years after surgery.

Secondary Measures

  • Disease-free survival
    • Time Frame: Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
    • It is the time from randomization to tumor progression or death (from any cause).
  • Overall survival
    • Time Frame: Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
    • It is the time from randomization to death (from any cause).
  • Cumulative annual recurrence and metastasis rate for 1-3 years
    • Time Frame: The day of surgery until the once, second and third year.
    • Refers to the proportion of patients with recurrence and metastasis within 1-3 years from the day of surgery.
  • Cumulative annual survival rate for 1-3 years
    • Time Frame: The day of surgery until the once, second and third year.
    • Refers to the proportion of patients with survical within 1-3 years from the day of surgery.
  • Indexes related to fat distribution
    • 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).
    • Total Fat Area, Visceral Fat Area and Subcutaneous Fat Area. They measure fat area on cross-sectional images using plain CT scanning.
  • Visceral Adiposity Index
    • 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).
    • 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).
  • Tumor marker
    • 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).
    • CEA
  • Tumor marker
    • 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).
    • SCC
  • Tumor marker
    • 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).
    • CYFR21-1
  • Tumor marker
    • 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).
    • CA199
  • Peripheral blood inflammatory index 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).
    • The ratio of lymphocytes to monocytes (LMR)
  • Peripheral blood inflammatory index 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).
    • The ratio of Lymphocyte to neutrophil ratio (LNR)
  • Prognostic nutritional index
    • 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).
    • Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 ^ 9 /L)
  • Quality of life of the patient (QLQ-QES18)
    • Time Frame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
    • 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.
  • Evaluation of the patient’s symptoms (MDASI-TCM)
    • Time Frame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
    • 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.
  • Medication compliance
    • Time Frame: From randomization to the end of the sixth course of medication (up to 24 weeks).
    • The number of cases and percentage were calculated as < 80%, 80-120% and > 120%
  • Percentage of Participants With Adverse Events
    • Time Frame: aseline until disease progression, death, or assessed up to 36 months after surgery.
    • Percentage of Participants With Adverse Events in different arms.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jie Li
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jie Li, Vice President – Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Overall Official(s)
    • Jie Li, Professor, Study Director, Guang ‘anmen Hospital, China Academy of Chinese Medical Sciences
    • Yu Wu, Professor, Principal Investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences
    • Shijie Zhu, Professor, Principal Investigator, Wangjing Hospital, China Academy of Chinese Medical Sciences
    • Guowang Yang, Professor, Principal Investigator, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
  • Overall Contact(s)
    • Bowen Xu, Doctor, +86 18811732383, 820850155@qq.com

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