Apatinib as Second-line Treatment of Advanced Pancreatic Cancer (Apslpanc)

This is an interventional treatment trial for Pancreatic Neoplasms Read More

Inclusion Criteria:

• ≥ 18 and ≤ 70 years of age,Male or female;
• The advanced pancreatic cancer pathology, with measurable lesions (spiral CT scan is more than 10mm, according to the standard of RECIST 1.1);
• Locally advanced, unresectable recurrent or metastatic pancreatic cancer;
• According to CTCAE 4.0 and patient complaints, the researchers determine second-line chemotherapy should not be tolerated by the patients or patients want to receive second-line chemotherapy.
• ECOG performance scale 0-1;
• Baseline blood routine and biochemical indexes meet the following criteria:
• Hemoglobin ≥ 80g/L,
• The absolute neutrophil count (ANC) ≥ 1.5 ×109/L,
• Blood platelet ≥ 90 ×109/L
• Alanine aminotransferase(ALT),Aspartate transaminase (AST) less than 2.5 times the upper limit of normal value, equal to or less than 5 times the upper limit of normal (liver metastasis),
• the serum total bilirubin is less than 1.5 times the upper limit of normal value,
• Serum creatinine. Less than 1.5 times the upper limit of normal value,
• Serum albumin is more than 30g/L;
• Life expectancy ≥ 3 months.
• women of childbearing age to within 7 days before entering the group of serum or urine pregnancy test and the results were negative. And be willing to give drug test during the test and the last 8 weeks using an appropriate method of contraception. For men, for sterilization, or agreed to during the period of the experiment and at the end of the given experimental drugs for 8 weeks by appropriate methods of contraception;
• In this study, volunteer subjects signed the informed consent, good compliance with follow-up.

Exclusion Criteria:

• It is confirmed that of apatinib and / or its accessories allergy;
• Have high blood pressure and antihypertensive drug treatment can not drop to normal range(systolic pressure >140 mmHg, diastolic blood pressure 90>mmHg), suffering from coronary artery disease above grade I, grade I arrhythmia (including corrected QT interval prolongation male > 450 ms, women > 470 MS) and grade I heart insufficiency; urine protein positive patients.
• Has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
• Coagulant function abnormality (INR>1.5, activated partial thromboplastin time(APTT)>1.5, ULN) with bleeding tendency;
• patients with central nervous system metastasis;
• pregnant or lactating women;
• Patients with other malignant tumors within five years;
• Has a history of psychiatric drugs abuse and can't quit or patients with mental disorders;
• 4 weeks participated in other clinical trials of patients;
• received VEGFR inhibitors, such as sorafenib, chougny for treatment;
• According to the researcher's judgment, there is serious to endanger the safety of patients or affect patients with disease to do the research;
• The researchers think that the person doesn't fit into.