| Eligibility |
Inclusion Criteria:
1. Over 18 years old;
2. Unresectable or relapses metastatic ampullary malignancies identified by
histopathology or cytology,with histological subtypes of parenteral type;
3. Have not received systematic treatment for unresectable or metastatic ampulla
malignant tumor;A scheme of adjuvant or neoadjuvant chemotherapy and 6 months after
the chemotherapy recurrence can into the group;
4. ECOG score 0 or 1;
5. Expected survival=12 weeks;
6. Have at least one measurable lesion;
7. Major organ functions within 7 days prior to treatment shall meet the following
criteria:
(1)Hemoglobin(HB)=90 g/L; (2)neutrophil absolute value(ANC)=1.5×109/L;
(3)Platelet(PLT)=100×109/L;
8.Biochemical examination shall meet the following standards:
1. Total bilirubin(TBIL)=3 times the upper limit of normal value(ULN);
2. ALT and aspartate aminotransferase AST=2.5×ULN,and ALT and AST=5×ULN with liver
metastasis;
3. Serum creatinine(Cr)=1.5×ULN or creatinine clearance(CCr)=60ml/min;
9.Doppler ultrasound evaluation:left ventricular ejection fraction(LVEF)=the lower limit of
normal value(50%);
10.Patients of reproductive age(including female and male patients'female companions)must
use effective birth control measures;
11.Subjects voluntarily joined the study and signed an informed consent form(ICF);
12.It is expected that the patient has good compliance and can follow up the efficacy and
adverse reactions according to the protocol requirements.
Exclusion Criteria:
1. Patients who have previously been treated with small-molecule drugs similar to
VEGFR-TKI,such as Anlotinib,Sunitinib,Sorafenib,Lenvatinib,Apatinib,etc.
2. Anti-pd-1 or anti-PD-L1/L2 antibodies or anti-cytotoxic T lymphocyte-associated
antigen(CTLA-4)antibodies were used in the past;
3. Malignant ampulla obstruction after clinical intervention was not resolved or
anti-infective therapy was required 14 days before the first study of drug therapy;
4. Patients with severe allergic history or allergic constitution;
5. Pregnant or lactating women;
6. Patients who have participated in other clinical trials and have not terminated the
trials;
7. Patients with any severe and/or uncontrolled medical condition,including:
(1)Patients with unsatisfactory blood pressure control(systolic blood pressure=150
mmHg,diastolic blood pressure=100 mmHg); (2)Patients with grade I or above myocardial
ischemia or myocardial infarction,arrhythmias(including QTc=480ms),and=grade 2 congestive
heart failure(New York Heart Association(NYHA)grades); (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)A history of immunodeficiency,including HIV
positive or other acquired or congenital immunodeficiency diseases,or a history of organ
transplantation; (7)Urine protein=++was indicated by two consecutive urine routine,and the
24-hour urine protein quantity was confirmed to be>1.0 g; (8)Mental illness,including
epilepsy,dementia,severe depression,mania,etc.
8.Received major surgical treatment,open biopsy,or significant traumatic injury within 28
days prior to grouping(specifically in conjunction with clinical evaluation);
9.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.;
10.The patient currently has active gastric and duodenal ulcers,ulcerative colitis and
other digestive diseases,or active bleeding from unexcised tumors,or other conditions
determined by researchers that may cause gastrointestinal bleeding and perforation;
11.Patients with any physical signs or history of bleeding,regardless of severity;Unhealed
wounds,ulcers,or fractures were observed in patients with any bleeding or bleeding
events=CTCAE grade 3 during the first 4 weeks of enrollment;
12.Experienced arteriovenous thrombotic events,such as cerebrovascular accidents(including
temporary ischemic attacks),deep vein thrombosis and pulmonary embolism,within 6 months;
13.Those who have a history of psychotropic substance abuse and cannot abstain or have
mental disorders;
14.Subjects with dysphagia or known drug absorption disorders.
15.The researchers considered other conditions unsuitable for inclusion.
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