gastric cancer
Conditions
Interventions
Conventional treatment group:chemotherapy combination with PD-1 inhibitor
Early multidisciplinary intervention group:On the basis of chemotherapy combined with PD-1 inhibitors, nutritional support was added to psychological counseling and enhance immune function
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age 18 to 75 years old, regardless of gender; Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction that has recurred after radical surgery; Eastern Cancer Collaboration Group (ECOG) body condition score (PS) 0 ~ 2; Expected survival more than 3 months; Within 7 days (including 7 days) prior to screening, laboratory test data should be: neutrophil count =1.5×109/L, platelet count =90×109/L, hemoglobin =90g/L (no blood transfusion within 14 days), serum total bilirubin =1.25 times the upper limit of normal (ULN); ALT and AST= 2.5 x ULN (patients with liver metastasis =5x ULN); Serum creatinine =1.0 x ULN and creatinine clearance =60ml/min; Left ventricular ejection fraction > 55% by ultrasonography; Subjects (or their legal representatives/guardians) must sign an informed consent indicating that they understand the purpose of the study, understand the required procedures, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: Previously received neoadjuvant chemotherapy for advanced gastric cancer, other than adjuvant therapy; received any investigational drug or antitumor drug in the 4 weeks prior to enrollment; unrecovered adverse effects of previous treatment above grade I (except alopecia); patients who are HER2-positive (HER2 IHC 3+ or IHC 2+ and FISH+) and are prepared to use herceptin; A history of other tumors within the past five years, excluding cured cervical cancer or basal cell carcinoma of the skin; symptomatic brain or meningeal metastases (unless the patient has been on treatment for > 6 months, imaging results are negative during the 4 weeks prior to study entry, and the clinical symptoms associated with the tumor are stable at study entry); Clinically significant active bleeding; The target lesion has received radiotherapy before; Pregnant or lactating women; Those who are fertile but do not take adequate contraceptive measures; Alcohol or drug addiction;H as multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, complete intestinal obstruction, etc.); Major organ failure or other serious disease, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina pectoris, symptomatic pericardial effusion, or unstable arrhythmia within the 6 months prior to enrollment; A history of severe neurological or psychiatric illness; Severe infection; Active disseminated intravascular coagulation or other concomitant disease that, in the investigator's judgment, seriously endangers patient safety or interferes with study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;QoL; | — |
Countries
China
Contacts
Public ContactLiu fenglin
Fudan University Shanghai Cancer Center
Outcome results
None listed