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

Not Applicable

Recruiting

• Conditions: Esophagus Cancer
• Interventions: Drug: Qizhu Yuling Prescription; Drug: Placebo

• Registration Number: NCT05626309
• Lead Sponsor: Jie Li

Brief Summary

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

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 Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-19
• Last Update Submitted: 2022-11-19
• Study First Posted: 2022-11-23
• Last Update Posted: 2022-11-23
• Primary Completion: 2024-08-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qizhu Yuling Prescription	Qizhu Yuling Prescription	Qizhu Yuling Prescription
Placebo Comparator	Placebo	Simulation agent of Qizhu Yuling Prescription Group

Primary Outcome Measures

Name	Time	Method
1-year disease-free survival rate	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 Outcome Measures

Name	Time	Method
Cumulative annual recurrence and metastasis rate for 1-3 years	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.
Indexes related to fat distribution	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.
Evaluation of the patient's symptoms (MDASI-TCM)	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	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%
Visceral Adiposity Index	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).
Peripheral blood inflammatory index 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).	The ratio of Lymphocyte to neutrophil ratio (LNR)
Quality of life of the patient (QLQ-QES18)	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.
Disease-free survival	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	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 survival rate for 1-3 years	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.
Tumor marker	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	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)
Prognostic nutritional index	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)
Percentage of Participants With Adverse Events	aseline until disease progression, death, or assessed up to 36 months after surgery.	Percentage of Participants With Adverse Events in different arms.

Trial Locations

Locations (3)

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Xiyuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Wangjing Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China