Clinical trial NCT03180476: Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma
Official title: Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2017-06-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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) =\<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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to 24 months
measure: Quality of Life (QoL) questionnaire
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Chendu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Mei Feng
role: PRINCIPAL_INVESTIGATOR
References: