Gastric Carcinoma Clinical Trial
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
The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Status | Recruiting |
Enrollment | 212 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Wangjing Hospital, China Academy of Chinese Medical Sciences | Beijing | Beijing |
China | Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | Beijing |
China | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong |
China | Jiangsu Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu |
China | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jie Li |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | The day of surgery until the second year. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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). | |
Secondary | 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). | |
Secondary | Tumor marker | CEA, CA724 and 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). | |
Secondary | Peripheral blood inflammatory index | The ratio of lymphocytes to monocytes (LMR) and 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). | |
Secondary | 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). | |
Secondary | 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. | Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery. | |
Secondary | 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. | Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery. | |
Secondary | 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). | |
Secondary | Percentage of Participants With Adverse Events | Percentage of Participants With Adverse Events in different arms. | Baseline until disease progression, death, or assessed up to 36 months after surgery. |
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