Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug safety.

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

Details

• Lead Sponsor: Sichuan Cancer Hospital and Research Institute
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• Male and female patients aged ranging from 18 to 75 years old.

• Naive or recurrent Nasopharyngeal Carcinoma with metastasis after chemotherapy or radiotherapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.

• Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =- Adequate renal function (creatinine clearance ≥ 60 mL/min).

• Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.

Exclusion Criteria:

• Previously, patients did receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.

• Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).

• Bleeding tendency or coagulation disorders.

• with brain metastases.

• Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).

• Urine protein≥++, or urine protein in 24 hours≥1.0g

• Severe uncured wounds, ulcers or fracture.

• Pregnant or breast-feeding.

• Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).

• Patients have these symptoms, such as neurological diseases, mental illness, serious infection.

• The researcher believe that the Patient is not suitable to participate in the study.