Vater ampulla carcinoma (VPC)
Conditions
Interventions
Experimental group:Surufatinib+CAPOX
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75, regardless of gender, willing to participate in the study and sign informed consent; 2. Histopathological diagnosis of unresectable/recurrent metastatic ampullary tumor; Contains Vater's ampulla, duodenal papilla, and lower common bile duct; 3. Prior surgery, radiotherapy or adjuvant therapy is required for at least 4 weeks; 4.ECOG score: 0-2; 5. Have at least one measurable lesion on CT, according to RECIST 1.1; 6. Expect to survive for at least 3 months. 7. Major organ functions within 7 days before treatment meet the following criteria: (1) Blood routine examination standards (no blood transfusion within 14 days) : (2) Hemoglobin (HB) =90 g/L; (3) Absolute value of neutrophil (ANC) =1.5×109/L; (4) Platelet (PLT) =100×109/L. 8. Biochemical tests should meet the following standards: (1) Total bilirubin (TBIL) =1.5 times normal upper limit (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×ULN or creatinine clearance (CCr)=60ml/min; 9. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = normal lower limit (50%). 10. Patients of reproductive age (including female and female partners of male patients) must use effective birth control measures; 11. The subjects voluntarily participated in the study and signed the informed consent (ICF); 12.It is expected that patients with good compliance will be able to follow up the efficacy and adverse reactions according to protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with VEGFR-TKI small molecule drugs, such as sunitinib, sorafenib; 2. Patients with a history of chemotherapy, radiotherapy or immunotherapy for ampullary tumor, except patients with recurrence 6 months after the last adjuvant therapy; 3. Patients with severe allergic history or allergic constitution; 4. Pregnant or lactating women; 5. Patients who have participated in other clinical trials in the past but have not terminated the trials; 6. Subjects at risk of gastrointestinal bleeding shall not be enrolled, including: (1) There are active ulcer lesions and occult blood in stool (++); (2) patients with history of black stools and hematemesis within 3 months; 7. Patients with any severe and/or uncontrolled disease, including: (1) Patients with poor blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); (2) patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc =480ms) and grade 2 congestive heart failure (NYHA classification); (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 requiring hemodialysis or peritoneal dialysis; (6) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; (7) Urine protein =++ indicated by two consecutive urine routine tests, and the 24-hour urine protein level was confirmed > 1.0g; (8) Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc. 8. Major surgical treatment, open biopsy or obvious traumatic injury within 28 days prior to grouping (combined with clinical evaluation); 9. Patients whose imaging shows that the tumor has invaded the periphery of important blood vessels or who are judged by researchers to be highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 10. Patients with any physical signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event =CTCAE grade 3 within 4 weeks prior to enrollment had unhealed wounds, ulcers or fractures; 11.Patients who have experienced arteriovenous or venous thrombosis events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 12. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 13. Subjects with difficulty swallowing or known drug absorption disorders. 14.There were other conditions that the researchers considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate, ORR;Disease Control Rate, DCR;Overall Survival,OS;security; | — |
Contacts
Public ContactTu Min
Jiangsu Province Hospital
Outcome results
None listed