Stage IV gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Group 1 :FLOT + apatinib + sintilimab
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. The newly diagnosed patients are confirmed by pathology (including histology or cytology) as gastric or gastroesophageal junction adenocarcinoma, accompanied by distant metastasis; 3. Before surgery, CT/MRI or color Doppler ultrasound, PET-CT, and if necessary, laparoscopy should be used to clearly diagnose the above staging of gastric cancer; 4. Newly diagnosed patients who have not received radiotherapy, chemotherapy, targeted therapy or immunotherapy before; 5. ECOGPS: 0-1 points; 6. Expected survival period >= 3 months; 7. No serious heart, lung, or liver dysfunction; no jaundice and digestive tract obstruction; no acute infection; 8. Patients with negative expression of HER2 or unknown expression; 9. The main organ functions are normal and meet the following criteria: (1) Blood routine inspection standards must meet (no blood transfusion within 14 days): 1) HB >= 100 g/L; 2) WBC >= 3.5 x 10^9/L; 3) ANC >= 1.5 x 10^9/L; 4) PLT >= 100 x 10^9/L; (2) Biochemical examination must meet the following standards: 1) BIL 60 ml/min (Cockcroft-Gault formula); 10. Did not participate in other clinical research before and during treatment; 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients with previous history of gastric cancer surgery, or patients with other malignant tumors; 2. Those who have confirmed hypersensitivity to apatinib and/or sintilimab and/or other drugs in the FOLT regimen; 3. Her-2 test positive, patients willing to receive Herceptin treatment; 4. Accompanied by severe heart, liver and kidney diseases; nervous and mental diseases; accompanied by severe infections; 5. Pregnant or lactating women; 6. Patients with high blood pressure who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 7. Suffering from grade I coronary heart disease, grade I arrhythmia (including QTc interval prolongation > 450 ms for men, > 470 ms for women) and grade I cardiac insufficiency; 8. Patients with a clear tendency of gastrointestinal bleeding, including the following conditions: patients with local active ulcer lesions and fecal occult blood (++); patients with a history of melena and hematemesis within 2 months; patients with abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN); 9. Patients with a history of cardiovascular and cerebrovascular diseases who are still taking thrombolytics or anticoagulants; 10. Patients with positive urine protein (urine protein detection 2+ or above, or 24-hour urine protein quantification > 1.0 g); 11. There are multiple factors that affect oral medication (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 12. The researchers think that they are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;Time to disease progression;Safety;Quality of Life;nutritional status;success rate of surgical conversion;surgical complications; | — |
Countries
China
Contacts
Public ContactJiao Zuoyi
Lanzhou University Second Hospital
Outcome results
None listed