gastric cancer
Conditions
Interventions
FLOT group :FLOT standard chemotherapy regimen
Combined group :FLOT chemotherapy regimen combined with Yiqi Huayu Jiedu decoction
Sponsors
Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced gastric cancer (World Health Organisation (WHO) criteria), TCM syndrome for spleen-stomach qi deficiency andstasis and toxin internal resistance syndrome, and have not received treatment before; 2. Males and females, aged 18-80 years; 3. Performance state: 0-2 (Eastern Cooperative Oncology Group (ECOG) ); sufficient bone marrow (white blood cell count > 3.0×10^9/L, platelet count >100×10^9/L); liver function (total bilirubin 50% by echo cardiography); kidney function (serum creatinine 50mL/min). No serious comorbidities that would result in an expected survival of less than 5 years; 4. Willing to participate in the research, and promise to follow the protocol and sign the informed consent. The process of obtaining informed consent should comply with GCP regulations.
Exclusion criteria
Exclusion criteria: 1. Diagnosed or highly suspected of distant metastasis, retroperitoneal lymph node metastasis, locally invasive unresectable tumor, recurrent gastric cancer, secondary malignant disease, and has received chemotherapy or radiotherapy previously; 2. Acute infectious diseases, uncontrollable systemic diseases or comorbidities or serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, known contraindications or adverse effects on chemotherapy drug or traditional Chinese medicine allergy; 3. History of malignant tumors, clear gastrointestinal bleeding tendency and/or coagulation dysfunction, poor blood pressure control and a history of myocardial infarction within 6 months; 4. Other Chinese and Western medicines for the treatment of advanced gastric cancer have been used after the onset of the disease; 5. Pregnant and lactating women; 6. Those who cannot give full informed consent due to intellectual or behavioral disabilities; 7. Suspected or confirmed history of alcohol and drug abuse; 8. Impaired renal, liver, heart, bone marrow and other hematopoietic function; 9. Circumstances that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up; 10. Participating in other research projects within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of nutritional status during perioperative period;Gut and intratumoral mcirobiota;short chain fatty acids;EMT related indicators;Immune Cell Related Indicators; | — |
Countries
China
Contacts
Public ContactZhenfeng Wu
Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed