advanced gastric cancer
Conditions
Interventions
Intervention group:Personalized second-line therapeutic regimen for each patient according to the PTC drug sensitivity test results
Sponsors
The Affliated Changzhou No. 2 People’s Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients with clinically suspected metastatic gastric cancer, which can be definitively diagnosed by histological or cytological means; 2. No previous history of radiotherapy and chemotherapy; 3. Have at least one measurable target lesion as defined by RECIST1.1 and at least one biopestible lesion (measurable and biopestible lesions can be the same), according to investigator assessment; 4. Age =18 years old, =85 years old, regardless of gender; 5. ECOG physical performance score 0-2; 6. Expected survival time =3 months; 7. The blood routine examination within 1 week before enrollment was almost normal (no blood transfusion or hematopoietic stimulation therapy within 2 weeks) : neutrophil count =1.5*109/L, hemoglobin =100g/L, platelet count =100*109/L; 8. Liver and kidney function tests within 1 week before enrollment were almost normal (the normal value of each laboratory was the standard) : total bilirubin =1.5* upper limit of normal, alanine aminotransferase =3* upper limit of normal (liver metastasis: =5* upper limit of normal), creatinine clearance =50ml/min; 9. The coagulation function test within 1 week before enrollment was almost normal: prothrombin time PT or INR = 1.5* upper limit of normal value, patients receiving anticoagulant therapy, INR within the prescribed range of anticoagulant drugs;
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors in the past 5 years, excluding cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma; 2. Patients requiring elective surgery during the trial; 3. Patients who are unable to swallow drugs orally or have conditions that seriously affect the absorption of gastrointestinal tract, such as chronic diarrhea and intestinal obstruction, which are not suitable for treatment; 4. Patients in pregnancy (positive pregnancy test) or lactation; 5. Central nervous system or meningeal metastasis; 6. Patients with uncontrolled bone metastasis, risk of fracture, surgery or local radiotherapy; 7. Patients with active infection requiring systemic anti-infective treatment; 8. A history of immunodeficiency, including HIV antibody positive patients; 9. Patients with known, active autoimmune diseases; 10. Patients with uncontrolled active hepatitis B, hepatitis C virus infection (hepatitis C antibody-positive); 11. Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: serious arrhythmia, acute coronary syndrome within half a year, congestive heart failure, aortic dissection, stroke, TIA history, etc 12. Severe bleeding events within half a year, or with high risk factors for bleeding such as active gastrointestinal ulcer, liver cirrhosis and esophagogastric varices; 13. Patients with diabetes that is not stably controlled with medications (including insulin); 14. Mental or language disorder, unable to communicate with the patient; 15. Patients enrolled in another clinical trial; 16. MSI-H/dMMR without immunotherapy; 17. Her-3+ Participants who were deemed by the investigator to have other serious systemic diseases or other conditions that would make them ineligible for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Duration of response;Success rate of establishing the PTC model; | — |
Countries
China
Contacts
Public ContactJiang Hua
The Affliated Changzhou No. 2 People’s Hospital of Nanjing Medical University
Outcome results
None listed