Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms Clinical Trial

Official title:

Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180476
• Other study ID #: Ahead-NC-201701
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2023
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Apatinib
Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. This agent also mildly inhibits c-Kit and c-SRC tyrosine kinases.

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital	Chendu	Sichuan

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The first day of treatment to the date that disease progression is reported	12 months
Secondary	Overall survival	the first day of treatment to death or last survival confirm date.	up to 24 months
Secondary	Quality of Life (QoL) questionnaire	in cancer patients and survivors with dermatologic conditions. This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis. Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s.	up to 24 months