Gastric cancer
Conditions
Interventions
Experimental Arm:Regular Diet + Nutrition Education + Suyisu Supplementation
Control Arm:Regular Diet + Nutrition Education + Standard Oral Nutritional Supplementation
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Unresectable locally advanced, recurrent or metastatic adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatic adenocarcinoma) confirmed by histopathological examination; 2. Age>=18 years old, and =60 points; 4. Expected survival time of more than 3 months; 5. Can be eaten orally, oral nutritional supplements (ONS), and no tube feeding/parenteral nutrition support is required after the doctor's assessment; 6. Previous systemic treatment regimens for advanced gastric cancer=1.5×10?/L; PLT>=80×10?/L; Hb>=90 g/L; Blood biochemistry: TBIL=50 mL/min (Cockcroft-Gault formula); 8. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the treatment period; 9. Voluntarily sign informed consent, willing to collect blood at the specified time point and cooperate with follow-up follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any regimen containing immune checkpoint inhibitors before enrollment; 2. Active, known, or suspected autoimmune disease or history of autoimmune disease within the past 2 years (exceptions include vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment within the past 2 years; hypothyroidism managed solely with thyroid hormone replacement therapy; or type I diabetes mellitus controlled exclusively with insulin replacement therapy); 3. Endoscopic evidence of active bleeding at the lesion site; 4. Fever or active infection (including active tuberculosis or viral hepatitis) within 14 days prior to enrollment; 5. Pregnancy (confirmed by serum ß-human chorionic gonadotropin test) or lactation; 6. Immunodeficiency disorders (including HIV infection) or history of organ transplantation; 7. Inability to consume food orally or require tube feeding/parenteral nutrition (or currently receiving such interventions); 8. Severe malnutrition incompatible with antitumor therapy; 9. Severe organ dysfunction or poor general health status; 10. Other conditions deemed ineligible for the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutritional Parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune Function Parameters; | — |
Countries
China
Contacts
Public ContactMinghua Cong
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed