Gastric cancer
Conditions
Interventions
Trial group (HSYW combined with XELOX chemotherapy):Huosu Nourishing Stomach Oral Liquid + XELOX chemotherapy
control group (XELOX chemotherapy alone):XELOX treatment regimen
Observation Group:None
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Age =18 and =75 years old, gender is not limited; 2)Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction, where the localised lesion is not amenable to radical resection or is metastatic gastric cancer; 3)not have received chemotherapy for locally advanced or metastatic disease and have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1 criteria); 4)Eastern Cooperative Oncology Group (ECOG) Physical Status Score (PS) 0 to 2; 5)KPS score = 60 and survival > 3 months; 6)Compliance with the spleen deficiency and stasis evidence in the TCM diagnostic criteria for gastric cancer; 7) Passing the laboratory test data requirements within 7 days prior to screening (including 7 days): neutrophil count =1.5 x 109/L, platelet count =90 x 109/L, haemoglobin =90g/L (no blood transfusion within 14 days), serum total bilirubin =1.25 times upper limit of normal (ULN); ALT and AST =2.5 x ULN (patients with liver metastasis =5x ULN); serum total bilirubin =1.25 times upper limit of normal (ULN); ALT and AST =2.5 x ULN (patients with liver metastases =5x ULN); serum total bilirubin =1.25 x ULN. ULN); serum creatinine = 1.0 x ULN and creatinine clearance = 60 ml/min; left ventricular ejection fraction > 55% on cardiac ultrasound; 8) Understand, agree to participate in this study and sign the informed consent form. Observation group: 1) Age = 18 years and = 75 years old, regardless of gender; 2) Pathological diagnosis of primary gastric cancer; 3) Complete clinical medical history and pathological data; 4) The traditional Chinese medicine syndrome differentiation is spleen deficiency and blood stasis syndrome.
Exclusion criteria
Exclusion criteria: (1) Previous chemotherapy for progressive gastric cancer, except for adjuvant therapy that ended >6 months prior to study entry; (2) Received any experimental or antineoplastic drug within 4 weeks prior to enrolment; (3) Presence of unrecovered adverse effects of previous treatment of degree I or higher (except alopecia); (4) Patients who are HER2 positive (HER2 IHC 3+ or IHC 2+ and FISH+) and are ready for first-line Herceptin; (5) History of other tumours within the previous five years, except cured cervical cancer or basal cell carcinoma of the skin; symptomatic brain or meningeal metastases (unless the patient has been on treatment for > 6 months, has had a negative imaging result within 4 weeks prior to entry into the study, and is clinically stable at the time of entry and tumour-related symptoms); (6) Clinically significant active haemorrhage; (7) Previous radiotherapy to the target lesion; (8) Pregnant or lactating women; those of childbearing potential who are not using adequate contraception; (9) Alcoholism or drug addiction; (10) Possession of multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhoea, complete intestinal obstruction, etc.); (11) Failure of vital organs or other serious illness, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina pectoris, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrolment; (12) History of severe neurological or psychiatric illness; serious infection; active disseminated intravascular coagulation or other concomitant illness that, in the investigator's judgement, seriously jeopardises the patient's safety or interferes with the patient's ability to complete the study. Observation group: (1) Gastric cancer with distant metastasis; (2) Gastric cancer combined with other malignant tumors; (3) Received preoperative treatments such as radiotherapy, chemotherapy, molecular targeting, immunology, and traditional Chinese medicine;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;AKR1C1 (Observation part); | — |
Secondary
| Measure | Time frame |
|---|---|
| Chinese Medicine Symptom Score;Chinese medicine evidence and efficacy;KPS score;Hypoxia-inducible factor-1a (HIF-1a);Matrix metalloproteinase-2 (MMP-2);Matrix metalloproteinase-9;CD3+;CD4+; CD4+/CD8+ cell ratio;safety assessment; | — |
Countries
China
Contacts
Public ContactFang shengquan
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed