Gastric cancer
Conditions
Interventions
Control group:Chemotherapy
Treatment group:Shenxia Kuanzhong Decoction combined with chemotherapy
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Pathologically confirmed as gastric adenocarcinoma tubular adenocarcinoma mucinous adenocarcinoma signet ring cell carcinoma (including adenocarcinoma and some signet ring cell carcinoma) staged as II~III according to the 8th edition TNM staging system having undergone radical surgery and postoperative adjuvant chemotherapy. (2) Meets the diagnostic criteria of both traditional Chinese and Western medicine with traditional Chinese medicine syndrome differentiation indicating spleen deficiency with phlegm-dampness type; (3) Age 18 to 80 years; (4) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; (5) Expected survival time = 6 months; (6) Laboratory tests within 7 days before enrollment (including the 7th day) meet the following requirements: neutrophil count = 1.5×10^9/L platelet count = 90×10^9/L hemoglobin = 90 g/L (no blood transfusion within 14 days) total serum bilirubin = 1.25 times the upper limit of normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the upper limit of normal serum creatinine = 1.0 times the upper limit of normal and creatinine clearance rate = 60 mL/min; (7) The patient or their authorized relative is informed of the treatment plan and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe cardiovascular diseases liver and kidney dysfunction and other severe organ function impairments; (2) Patients with other acute or chronic infectious diseases and those with severe infections; (3) Pregnant and breastfeeding women; (4) Patients with severe acid-base imbalance and electrolyte disorders; (5) Patients with concurrent active gastrointestinal bleeding; (6) Patients with concurrent sepsis or bacteremia; (7) Patients diagnosed with mental disorders and cognitive impairment; (8) Patients with other syndrome types except for spleen deficiency with phlegm-dampness type according to traditional Chinese medicine differentiation; (9) Those who are taking other Chinese patent medicines or similar treatments simultaneously; (10) Those known to be allergic to Chinese medicine; (11) Those participating in other research projects simultaneously; (12) Those who do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative Dose Intensity;Longitudinal Cumulative Dose;Chemotherapy completion rate;Degree of bone marrow suppression after chemotherapy;Quality of life assessment;Nutritional status assessment;Systemic inflammation index;Tumor marker; | — |
Countries
China
Contacts
Public ContactZhihong Fang
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed