Apatinib as Second-line Treatment of Advanced Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main research purpose Evaluation of objective response Apatinib second-line treatment of advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS).

Objective to study the objective and exploratory secondary research To observe the Apatinib in second line treatment of advanced pancreatic cancer disease control rate (DCR), patients with overall survival (OS) benefit, treatment effects on quality of life (QOL) score and drug safety evaluation, To investigate the relationship of apatinib as second-line treatment of advanced pancreatic cancer and the expression of vascular endothelial growth factor receptor(VEGFR) in the serum

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Apatinib

Criteria

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.