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Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Neoplasms

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sichuan Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apatinib

Arm Description

apatinib,500mg,qd，28 day/cycle until the emergence of PD, death, intolerable toxicity

Outcomes

Primary Outcome Measures

Progression-free survival

The first day of treatment to the date that disease progression is reported

Secondary Outcome Measures

Overall survival

the first day of treatment to death or last survival confirm date.

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.

Full Information

NCT ID

NCT03180476

First Posted

June 6, 2017

Last Updated

April 13, 2023

Sponsor

Sichuan Cancer Hospital and Research Institute

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03180476

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan Cancer Hospital and Research Institute

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

apatinib

Arm Type

Experimental

Arm Description

apatinib,500mg,qd，28 day/cycle until the emergence of PD, death, intolerable toxicity

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

YN968D1, apatinib mesylate tablets

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

The first day of treatment to the date that disease progression is reported

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

the first day of treatment to death or last survival confirm date.

Time Frame

up to 24 months

Title

Quality of Life (QoL) questionnaire

Description

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mei Feng

Organizational Affiliation

Sichuan Cancer Hospital and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sichuan Cancer Hospital

City

Chendu

State/Province

Sichuan

ZIP/Postal Code

600000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma

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