gastric cancer
Conditions
Interventions
Experimental Group:Standard chemotherapy combined with Yiqi Jiedu decoction oral therapy.
Control Group:Standardized chemotherapy
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: The following diagnostic criteria are met: In terms of Western medicine, the patient has been definitively diagnosed with gastric malignant tumor via endoscopy and biopsy (based on the "Guidelines for the Diagnosis and Treatment of Gastric Cancer (2025 Edition)"), and has undergone radical resection for gastric cancer. The postoperative pathological staging, confirmed according to the "AJCC Cancer Staging Manual (8th Edition)," is classified as stage II or III, with no recurrence. In terms of traditional Chinese medicine, the criteria for "Qi deficiency with blood stasis and toxicity" are met-primary symptoms include manifestations of Qi deficiency (e.g., shortness of breath, reluctance to speak, fatigue, and lack of spirit) or blood stasis and toxicity (e.g., stabbing pain in the epigastrium, fixed pain that resists pressure, or intermittent stabbing pain), accompanied by secondary symptoms such as a dark complexion, spontaneous sweating, postprandial epigastric distension and pain, poor appetite, nausea and vomiting, dry mouth without thirst, continuous abdominal pain, and subcutaneous ecchymosis, among others, with at least one symptom present. Additionally, the tongue may exhibit a pale dark or purple dark color, with ecchymoses or petechiae at the edges, a thickened tongue body, thin or white greasy coating, and the pulse may present as weak, fine and thready, absent, deep and string-like, or deep and slow. Individuals who meet one primary symptom, one or more secondary symptoms, and possess the corresponding tongue and pulse characteristics may be included in this study. 2: 18 years = age = 75 years; 3: Karnofsky Performance Status (KPS) score > 60, with an expected survival period > 6 months; 4: Possess basic cognitive and communication abilities, voluntarily sign the informed consent form, be willing to accept the interventions related to this study, and cooperate with completing questionnaires and the collection of tongue coating and stool samples.
Exclusion criteria
Exclusion criteria: 1: Patients with a confirmed diagnosis of metastatic gastric cancer 2: Patients unable to eat orally (e.g., complete gastrointestinal obstruction, placement of a jejunostomy tube, etc.) 3: Patients with abnormal laboratory findings prior to enrollment: Blood routine: ANC 1.5×upper limit of normal (ULN), or creatinine clearance 1.5×ULN, ALT or AST > 1.5×ULN; 4: Patients with a history of upper respiratory tract infection within 1 month prior to enrollment, and who have previously used antibiotics or probiotic drugs (including oral or intravenous administration) 5: Patients with severe systemic diseases or functional impairments, such as autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, hyperthyroidism, etc.), a history of or concurrent other malignancies, severe heart, lung, liver, or kidney dysfunction, or moderate to severe chronic pain affecting quality of life 6: Pregnant or breastfeeding women 7: Patients with poor compliance who are unable to complete the sample collection and follow-up required by the study 8: Patients with a clear history of allergy to the study drug (Yiqi Jiedu Formula) or its components 9: Patients with a history of alcohol abuse or other drug abuse 10: Patients currently participating in other interventional clinical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tongue Coating Metabolome Profile;Tongue coating microbiota structure;Fecal metabolite profile;Gut microbiota structure;Nutritional status (BMI, NRS-2002, and PG-SGA scores);Quality of Life (EORTC QLQ-C30 and STO22 assessments);TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactQiu Shengliang
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed