gastric cancer
Conditions
Interventions
Experimental group:sintilimab+fruquintinib+albumin-bound paclitaxel
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years old, gender not limited, voluntary testing and signing informed consent; 2. Pathologically confirmed advanced gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) with extragastric measurable disease (RECIST 1.1 criteria); 3. Accept the first-line dilip single joint failure of standard chemotherapy in treating advanced its ehrs resistance - 2 negative patients with gastric cancer; Patients who did not have clinical benefit (PD as the best response to treatment) after at least 12 weeks of sintilimab treatment were not allowed. 4.ECOG score: 0-1; 5. Expected to survive at least more than 3 month. 6. The main organ within 7 days before the treatment, meet the following criteria: (1) hemoglobin (HB) =90 g/L; (2) white blood cell =3.5×109/L; (3) the neutrophils absolute value (ANC) acuity 1.5 x 109 / L; (4) platelet count =100×109/L. 7. Biochemical tests must meet the following criteria: (1) Total bilirubin (TBIL) =1.5 times the upper limit of normal value (ULN); (2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN, if accompanied by liver metastasis, ALT and AST=5×ULN; (3) serum creatinine (Cr) 1.5 x ULN or less or creatinine clearance (CCr) or 60 ml/min; 8. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50% lower limit of normal value. 9. Patients of childbearing age (including female patients and female partners of male patients) must take effective measures of birth control; 10. Participants voluntarily participated in the study and signed the informed consent form (ICF); 11. Good compliance is expected, and the efficacy and adverse reactions can be followed up according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Used VEGFR-TKI small molecule drugs in the past, such as sunitinib, sorafenib, anlotinib, lenvatinib and other anti-angiogenic drugs; 2. Previous treatment with other immune checkpoint inhibitors other than sindillizumab; 3. Patients who had previously discontinued treatment due to immune-related toxicity during sindillizumab treatment; 4. Previous treatment of patients with paclitaxel drugs; 5. Patients with severe allergic history or allergic constitution; 6. Pregnant or lactating women; 7. Patients who have participated in other clinical trials and have not yet terminated the trial; 8. Patients with a definite tendency to gastrointestinal bleeding. Including the following conditions: ? there are locally active ulcer lesions, and stool occult blood 2+ or more; (Fecal occult blood 2+ was allowed to re-test fecal occult blood, and patients who were judged by the investigator to have clear benefits could be enrolled); ? Patients with history of black stool and hematemesis within 3 months; 9. Patients with any severe and/or uncontrolled disease, including: (1) Patients with unsatisfactory blood pressure control (systolic pressure =150 mmHg, diastolic pressure =100 mmHg); (2) have grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc =480ms), and = grade 2 congestive heart failure (NYHA); (3) Active or uncontrolled severe infection (=CTC AE grade 2 infection); (4) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (7) Two consecutive urine routine indicated urine protein =++, and confirmed that the 24-hour urine protein quantity > 1.0 g; (8) Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc. 10. Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the grouping (specifically in conjunction with clinical evaluation); 11. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc.; 12. Patients whose imaging shows that the tumor has invaded important blood vessels, or who are judged by the investigators to be highly likely to invade important blood vessels and cause fatal major bleeding during follow-up studies; 13. Patients with any physical signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding events =CTCAE grade 3, unhealed wounds, ulcers, or fractures during the first 4 weeks of enrollment; 14.6 months after the occurrence of arterial/venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 15. Patients with brain metastases accompanied by symptoms or symptoms controlled for less than 2 months; 16. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 17. Subjects with dysphagia or known drug absorption disorders; 18. Patients with ascites or pleural effusion with clinical symptoms; 19.The researchers determined that there were other conditions that were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Disease control rate, DCR;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactGuo Renhong
Jiangsu Cancer Hospital
Outcome results
None listed