apatinib, irinotecan and s-1 (apairis) in treating patients with metastatic pancreatic cancer after ag regimen

Conditions: Metastatic Pancreatic Cancer

Summary: this is a single arm, open label phase ii clinical trial to evaluate the efficacy and safety of apatinib combined with irinotecan and s-1 (apairis) in treating patients with metastatic pancreatic cancer after chemotherapy with albumin-bound paclitaxel plus gemcitabine regimen

while ag (albumin-bound paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after ag regimen. in this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received apatinib, irinotecan and s-1. treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. the efficacy and safety data will be assessed through pfs, os, orr and adverse effects as graded by ctc-ae 5.0.

Eligibility criteria:
inclusion criteria: * informed consent and willing to complete the study according to the protocol * ecog performance scale ≤ 2; * diagnosed as pancreatic adenocarcinoma by histology and cytology; * treatment of patients with advanced metastatic pancreatic cancer who have failed with ag (albumin and gemcitabine) regimen * baseline blood routine and biochemical indexes meet the following criteria: 1. blood routine examination criteria must be met: (no blood transfusion within 14 days) 1. hb≥90g/l； 2. anc≥1.5×109/l； 3. plt≥80×109/l 2. biochemical tests are subject to the following criteria: 1. bil \<1.25xuln ； 2. alt and ast\<2.5uln； 3. serum creatinine. less than 1 times the upper limit of normal value, endogenous creatinine clearance\>50ml/min ( cockcroft-gault formula). * the advanced pancreatic cancer pathology, with measurable lesions (spiral ct scan is more than 10 mm, according to the standard of recist 1.1); * life expectancy ≥ 12 weeks; * doctors believe that treatment can bring benefits to patients. exclusion criteria: * unwilling or unable to comply with the study protocol; * other or malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; * allergy to apatinib, s-1 raw materials and/or their excipients; * received vegfr inhibitors, such as sorafenib, chougny for treatment; * 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. * renal insufficiency, patients with previous kidney disease, urine protein positive (urinary protein detection 2+ or above, or 24-hour urine protein quantitation \> 1.0g); * has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) * pregnant or lactating women; * coagulant function abnormality (inr\>1.5、aptt\>1.5 uln) with bleeding tendency; those with bleeding tendency (such as active ulcerative lesions in the stomach, fecal occult blood (++), vaginal and/or hematemesis within 3 months, hemoptysis) or lesions close to the large vessel site; * patients with a deficiency of dihydropyrimidine dehydrogenase are known; * evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, hiv infection, high blood pressure, severe arrhythmia, diabetes, massive active bleeding); * patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; * according to the investigator's judgment, there are other serious patients who are at risk to the patient's safety or affect the patient's accompanying disease.

Keywords: metastatic pancreatic cancer pancreatic adenocarcinoma apatinib s-1 irinotecan