Gastric cancer
Conditions
Interventions
Control group:Chemotherapy combined with placebo
Sponsors
Jiangsu Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
65 Years to 95 Years
Inclusion criteria
Inclusion criteria: Gastric cancer patients who have undergone D2 lymph node dissection and R0 resection and are scheduled to receive the postoperative S1 monotherapy /SOX regimen; (2) Postoperative pathological diagnosis of gastric cancer, with pathological stage pII/pIII (American Joint Committee on Cancer Classification, AJCC); (3) Those who have been confirmed by imaging examinations to have no recurrence or metastasis; (4) The PS score is 0 to 2 points. (5) Age =65 years old; (6) Generally normal bone marrow, liver and kidney functions: Bone marrow function: Neutrophil count =1.5×109/L, platelet count =100×109/ L, hemoglobin =90g/L; Renal function: Serum creatinine =1.5mg/dl (133µmol/L) and/or creatinine clearance =60ml/min; Liver function: Total serum bilirubin level =1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) & alanine aminotransferase (ALT) =2.5 times ULN. (7) Sign the informed consent form and the patient voluntarily accepts the treatment plan.
Exclusion criteria
Exclusion criteria: (1) Those who are unable to complete the baseline assessment. (2) Those who are planned to receive postoperative adjuvant radiotherapy. (3) Those with primary tumors in other parts. (4) Those with a history of hematological diseases a history of organ transplantation or those who need to take oral immunosuppressants for a long time. (5) Those with severe primary heart liver lung or kidney diseases or those with severe diseases that affect their survival. (6) Those who have received traditional Chinese medicine treatment within the past 6 weeks. (7) Those who have a fever with a body temperature higher than 38°C within 3 days before enrollment or have clinically significant infections. (8) Those who have participated in other clinical trials within the past 3 months. (9) Pregnant women lactating women those with mental illnesses intellectual or language impairments those without legal capacity and those for whom medical or ethical reasons affect the continuation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall chemotherapy completion rate;TCM Syndrome Score;Quality of Life Score;Overall survival time; | — |
Countries
China
Contacts
Public ContactPeng Shu
Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine)
Outcome results
None listed