Clinical trial NCT05229809: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastric Carcinoma
Keywords: Postoperative gastric cancer
Yiqi Wenyang Jiedu prescription
Chinese Herbal Medicine
Randomized Controlled Trial
2-year disease-free survival rate
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 2-year disease-free survival rate
timeFrame: The day of surgery until the second year.
Secondary outcomes:
measure: Disease-free survival
timeFrame: Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
measure: Overall survival
timeFrame: Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
measure: Cumulative annual recurrence and metastasis rate for 1-3 years
timeFrame: The day of surgery until the once, second and third year.
measure: Cumulative annual survival rate for 1-3 years
timeFrame: The day of surgery until the once, second and third year.
measure: Indexes related to fat distribution
timeFrame: 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).
measure: Visceral Adiposity Index
timeFrame: 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).
measure: Tumor marker
timeFrame: 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).
measure: Peripheral blood inflammatory index
timeFrame: 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).
measure: Prognostic nutritional index
timeFrame: 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).
measure: Quality of life of the patient
timeFrame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
measure: Evaluation of the patient's symptoms
timeFrame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
measure: Medication compliance
timeFrame: From randomization to the end of the sixth course of medication （up to 24 weeks）.
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline until disease progression, death, or assessed up to 36 months after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Wangjing Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
name: Jie Li, Professor
role: STUDY_DIRECTOR
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Yu Wu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Wangjing Hospital, China Academy of Chinese Medical Sciences
name: Shijie Zhu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Hong Zhao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Lizhu Lin, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
name: Ling Xu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Hospital of Traditional Chinese Medicine
name: Peng Shu, Professor
role: PRINCIPAL_INVESTIGATOR
References: