Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma

University of Electronic Science and Technology of China (UESTC)

Status and phase

Completed

Phase 2

Conditions

Nasopharyngeal Neoplasms

Treatments

Drug: Apatinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03180476

Ahead-NC-201701

Details and patient eligibility

About

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.

Full description

In locally advanced nasopharyngeal carcinoma(NPC), although radiotherapy and chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for metastatic NPC who failed to chemoradiotherapy therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib as maintenance therapy after chemoradiotherapy in nasopharyngeal carcinoma with metastasis.

Enrollment

21 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5).
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.