Gastric Cancer
Conditions
Interventions
experimental group:Qiling Modulating Yuan Drink combined with XELOX (oxaliplatin capecitabine) chemotherapy
Control groups:XELOX (oxaliplatin capecitabine) chemotherapy
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form. 2. Age > = 18 years old and =3 months. 5. Meet the Western medical diagnostic criteria for advanced gastric cancer (TNM stage is stage IV). 6. Meet the diagnostic criteria of traditional Chinese medicine for the diagnosis of gastric cancer with medium deficiency and qi stagnation. 7. At least one measurable tumor lesion according to RECIST v1.1 criteria. 8. Good organ function as determined by the following requirements: a) hematology: i. neutrophil count (ANC) >=1.5×10^9/L (1,500/mm^3); ii. Platelet count>=100×10^9/L (100,000/mm^3); iii. Hemoglobin > = 9.0 g/dL within 2 weeks prior to the first dose. b) Renal: i. Serum creatinine = 60 mL/min. c) Liver: i. Total bilirubin (TBil) =28g/L. d) Coagulation: i. International normalized ratio and activated partial thromboplastin time < = 1.5× ULN.
Exclusion criteria
Exclusion criteria: 1. Human epidermal growth factor 2 (HER2) positive. 2. Have squamous cell or undifferentiated or other histologic types of gastric or gastroesophageal junction cancer. 3. Those who have participated in or are participating in other clinical trials within 4 weeks. 4. Presence of inability to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect the taking and absorption of drugs. 5. Central nervous system (CNS) metastases, or meningeal metastases, spinal cord compression, and leptomeningeal diseases. 6. Presence of clinically active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction. 7. Presence of important organ failure or other serious diseases, including clinically relevant coronary artery disease, cardiovascular disease or myocardial infarction, congestive heart failure, unstable angina, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months prior to enrollment. 8. The target lesion has received radiotherapy. 9. Presence of toxicities that have not been resolved: Toxicities that have not been resolved by prior anticancer therapy (defined as those that have not resolved to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (NCI CTCAE v5.0) = Grade 2), except for alopecia. 10. Those who are allergic to treatment drugs. 11. Pregnant or lactating females, of childbearing potential and not taking adequate contraceptive measures. 12. Presence of a history of severe neurological or psychiatric illness, severe infection, active disseminated intravascular coagulation, or other concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Indicators of the efficacy of Chinese medicine signs and symptoms;Indicators of quality of life outcomes;Grading of adverse reactions;CT examination; | — |
Countries
China
Contacts
Public ContactFang Shengquan;Tian Jinli
Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, China
Outcome results
None listed