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Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer

Primary Purpose

Gastric Carcinoma

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Yiqi Wenyang Jiedu prescription
Simulation agent of Yiqi Wenyang Jiedu prescription
Sponsored by
Jie Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Carcinoma focused on measuring Postoperative gastric cancer, Yiqi Wenyang Jiedu prescription, Chinese Herbal Medicine, Randomized Controlled Trial, 2-year disease-free survival rate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The non-esophagogastric junction gastric cancer of stage II-III that met the diagnostic criteria, and no tumor recurrence and metastasis was determined by imaging;
  2. Within 6-8 months after radical gastrectomy for gastric cancer (R0), adjuvant chemotherapy of standard regimen (XELOX and SOX) has been completed for at least 6 cycles;
  3. ECOG score 0-2;
  4. 18-75 years old, male or female;
  5. The expected survival time is ≥3 months;
  6. Voluntary participation in the study, signing informed consent, good compliance with follow-up.

Exclusion Criteria:

  1. Patients with other primary tumors;
  2. Gastric cancer patients were pathologically diagnosed as adenosquamous carcinoma, with lymphoid stromal carcinoma (medullary carcinoma), hepatoid adenocarcinoma, squamous cell carcinoma, signed-ring cell carcinoma, undifferentiated carcinoma, gastric neuroendocrine tumor, gastric mesenchymal tumor, gastric malignant lymphoma and other gastric malignancies;
  3. Patients who had previously received preoperative neoadjuvant chemotherapy;
  4. Patients with past or current targeted drug therapy;
  5. Patients undergoing previous or ongoing gastric radiotherapy;
  6. Patients with past or ongoing tumor immunotherapy;
  7. Mental patients;
  8. Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;
  9. Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months;
  10. Patients who are known to be allergic or intolerant to the study drug.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
  • Xiyuan Hospital, China Academy of Chinese Medical SciencesRecruiting
  • Wangjing Hospital, China Academy of Chinese Medical SciencesRecruiting
  • The First Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting
  • Jiangsu Hospital of Traditional Chinese MedicineRecruiting
  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yiqi Wenyang Jiedu prescription Group

Simulation agent of Yiqi Wenyang Jiedu prescription Group

Arm Description

Outcomes

Primary Outcome Measures

2-year disease-free survival rate
Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 2 years after surgery.

Secondary Outcome Measures

Disease-free survival
It is the time from randomization to tumor progression or death (from any cause).
Overall survival
It is the time from randomization to death (from any cause).
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.
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.
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.
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).
Tumor marker
CEA, CA724 and CA199
Peripheral blood inflammatory index
The ratio of lymphocytes to monocytes (LMR) and ratio of Lymphocyte to neutrophil ratio (LNR)
Prognostic nutritional index
Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 ^ 9 /L)
Quality of life of the patient
This will be measured with Quality of Life Questionnaire of Stomach22 (QLQ-STO22). The minimum score is 22 and the maximum is 88. A higher score indicates a poorer quality of life.
Evaluation of the patient's symptoms
This will be measured with M. D. Anderson Symptom Inventory (MDASI-GI) and Postgastrectomy Syndrome Assessment Scale (PGSAS-45). The minimum score of MDASI-GI is 0 and the maximum is 240. The minimum score of PGSAS-45 is 0 and the maximum is 271. A higher score indicates a poorer symptom.
Medication compliance
The number of cases and percentage were calculated as < 80%, 80-120% and > 120%
Percentage of Participants With Adverse Events
Percentage of Participants With Adverse Events in different arms.

Full Information

First Posted
January 15, 2022
Last Updated
October 31, 2022
Sponsor
Jie Li
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1. Study Identification

Unique Protocol Identification Number
NCT05229809
Brief Title
Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer
Official Title
Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Detailed Description
This study include a multicenter, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 212 patients. Participants will be randomly divided into experimental (n=106) and control groups (n=106).Patients in the experimental group was treated with Yiqiuyang Jiedu prescription within 6-8 months after radical gastroctomy and after the completion of standard regimen (XELOX and SOX) for at least 6 cycles of adjuvant chemotherapy. Patients in the control group will receive the placebo.The primary endpoint is 2-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 2 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Carcinoma
Keywords
Postoperative gastric cancer, Yiqi Wenyang Jiedu prescription, Chinese Herbal Medicine, Randomized Controlled Trial, 2-year disease-free survival rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yiqi Wenyang Jiedu prescription Group
Arm Type
Experimental
Arm Title
Simulation agent of Yiqi Wenyang Jiedu prescription Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Yiqi Wenyang Jiedu prescription
Intervention Description
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 gastric cancer surgery.
Intervention Type
Drug
Intervention Name(s)
Simulation agent of Yiqi Wenyang Jiedu prescription
Intervention Description
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 gastric cancer surgery.
Primary Outcome Measure Information:
Title
2-year disease-free survival rate
Description
Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 2 years after surgery.
Time Frame
The day of surgery until the second year.
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
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.
Title
Overall survival
Description
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.
Title
Cumulative annual recurrence and metastasis rate for 1-3 years
Description
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.
Title
Cumulative annual survival rate for 1-3 years
Description
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.
Title
Indexes related to fat distribution
Description
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).
Title
Visceral Adiposity Index
Description
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).
Title
Tumor marker
Description
CEA, CA724 and 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).
Title
Peripheral blood inflammatory index
Description
The ratio of lymphocytes to monocytes (LMR) and 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).
Title
Prognostic nutritional index
Description
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).
Title
Quality of life of the patient
Description
This will be measured with Quality of Life Questionnaire of Stomach22 (QLQ-STO22). The minimum score is 22 and the maximum is 88. 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.
Title
Evaluation of the patient's symptoms
Description
This will be measured with M. D. Anderson Symptom Inventory (MDASI-GI) and Postgastrectomy Syndrome Assessment Scale (PGSAS-45). The minimum score of MDASI-GI is 0 and the maximum is 240. The minimum score of PGSAS-45 is 0 and the maximum is 271. 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.
Title
Medication compliance
Description
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）.
Title
Percentage of Participants With Adverse Events
Description
Percentage of Participants With Adverse Events in different arms.
Time Frame
Baseline until disease progression, death, or assessed up to 36 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The non-esophagogastric junction gastric cancer of stage II-III that met the diagnostic criteria, and no tumor recurrence and metastasis was determined by imaging; Within 6-8 months after radical gastrectomy for gastric cancer (R0), adjuvant chemotherapy of standard regimen (XELOX and SOX) has been completed for at least 6 cycles; ECOG score 0-2; 18-75 years old, male or female; The expected survival time is ≥3 months; Voluntary participation in the study, signing informed consent, good compliance with follow-up. Exclusion Criteria: Patients with other primary tumors; Gastric cancer patients were pathologically diagnosed as adenosquamous carcinoma, with lymphoid stromal carcinoma (medullary carcinoma), hepatoid adenocarcinoma, squamous cell carcinoma, signed-ring cell carcinoma, undifferentiated carcinoma, gastric neuroendocrine tumor, gastric mesenchymal tumor, gastric malignant lymphoma and other gastric malignancies; Patients who had previously received preoperative neoadjuvant chemotherapy; Patients with past or current targeted drug therapy; Patients undergoing previous or ongoing gastric radiotherapy; Patients with past or ongoing tumor immunotherapy; Mental patients; Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy; Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months; Patients who are known to be allergic or intolerant to the study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guanghui Zhu, Doctor
Phone
+86 13315714979
Email
zhugh0822@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Li, Professor
Organizational Affiliation
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yu Wu, Professor
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shijie Zhu, Professor
Organizational Affiliation
Wangjing Hospital, China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Zhao, Professor
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lizhu Lin, Professor
Organizational Affiliation
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ling Xu, Professor
Organizational Affiliation
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peng Shu, Professor
Organizational Affiliation
Jiangsu Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhao
Facility Name
Xiyuan Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Wu
Facility Name
Wangjing Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shijie Zhu
Facility Name
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizhu Lin
Facility Name
Jiangsu Hospital of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Shu
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200437
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Xu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer

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