Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer (ASPC)

Inclusion criteria:

• 18-70 years old;
• ECOG score: 0-2;
• Have confirmed metastatic or locally advanced unresectable pancreatic cancer;
• At least one measurable lesion according to the RECIST1.1 standard;
• First-line chemotherapy drugs do not include S-1 or fluorouracil drugs;

• Main organ functions meet the following standards:

  • Baseline blood routine (the inspection standard should meet the requirements of no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulant correction) :

    • Hemoglobin>80g/L
    • The absolute neutrophil count (ANC) 1.5 x 109 / L;
    • Blood platelet (PLT)> 90 x 109 / L;

  • Baseline biochemical test shall meet the following standards:

    • T BIL < 1.5*ULN.
    • A LT and AST<2.5*ULN, and in patients with liver metastasis < 5*ULN;
    • Cr≤1.5*ULN.
    • Albumin is greater than or equal to 30g/L;
• Women of child-bearing age must already have access to reliable contraception. Pregnancy tests (serum or urine) were performed within 7 days prior to enrollment and the results were negative, and a reliable method of contraception was preferred 8 weeks after the trial period and the last drug administration;
• Subjects will voluntarily join the study and sign the informed consent.

Exclusion criteria:

• Clearly allergic to apatinib, S-1 or their excipients;
• There are various factors affecting oral drugs (including dysphagia, chronic diarrhea, intestinal obstruction, etc.);

• Serious heart diseases in the last six months, including :

  • angina;
  • myocardial infarction;
  • heart failure;
  • interphase of QTc >450ms;
  • any other heart diseases that were judged as unsuitable for the study;
• Combined with uncontrollable hypertension after drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);
• Complicated with other serious medical diseases, including cerebrovascular disease, uncontrolled infection, active peptic ulcer, intestinal obstruction, etc.;
• Metastasis of tumor central nervous system;
• Women during pregnancy and lactation;
• The patient has been diagnosed with other tumors in the past five years, except for the following situations: B. Cured basal cell carcinoma of the skin and cured orthotopic carcinoma of the cervix;
• The time from the last chemotherapy is shorter than 4 weeks or 5 half-life (the time taken is older), and the time from the last radiotherapy is shorter than 4 weeks;
• Use the experimental drug within 28 days before enrollment;
• Patients with grade 2 or above toxicity caused by the use of anti-tumor drugs before enrollment;
• Have mental disorders or a history of substance abuse;
• Other circumstances that the investigator deems inappropriate to participate in the study;