Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

Brief Title

Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

Official Title

A Multicenter, Phase II Clinical Study of Adjuvant Apatinib After IMRT With Concurrent Chemotherapy Versus IMRT With Concurrent Chemotherapy in High-risk Metastasis of Nasopharyngeal Carcinoma

Brief Summary

      The study is to evaluate the efficacy and safety of apatinib for adjuvant treatment of
      High-risk metastasis of nasopharyngeal carcinoma after IMRT with concurrent
      chemotherapy,including progression-free survival (PFS),evaluation of drug safety.,and overall
      survival (OS),distant metastasisfree survival (DMFS),locoregional relapse-free survival
      (LRRFS),and quality of life score (QoL).
    

Detailed Description

      PRIMARY OBJECTIVES:

      Ⅰ.To determine if adjuvant apatinib after IMRT with concurrent chemotherapy is better to only
      obeservation after IMRT with concurrent chemotherapy for progression-free survival in
      High-risk metastasis of nasopharyngeal carcinoma.

      SECONDARY OBJECTIVES:

      Ⅰ.To explore the adjuvant medication regimen of local advanced nasopharyngeal carcinoma after
      IMRT with concurrent chemotherapy.

      Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment
      strategy of nasopharyngeal carcinoma patients.

      OUTLINE:

      Patients are randomized to one of the two treatment arms.

      ARM 1: treat with apatinib(the dose was 250 mg,orally,qd,28 days for an observation
      period,Six cycles) for adjuvant treatment of local advanced nasopharyngeal carcinoma after
      IMRT with concurrent chemotherapy.

      ARM 2:only obeservation after IMRT with concurrent chemotherapy. IMRT: GTVnx 69.69Gy, GTVnd
      60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.

      Concurrent chemotherapy:Cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.

      After completion of study therapy, patients are followed up every 3-4 months for 2 years,
      then every 6 months for 3 years.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression-free survival

Secondary Outcome

 Overall survival

Condition

Nasopharyngeal Carcinoma

Intervention

Apatinib mesylate tablet

Study Arms / Comparison Groups

 IMRT with CC+Adjuvant Apatinib

Description:  Treat with Apatinib mesylate tablet for adjuvant treatment(the dose was 250 mg,orally,qd,28 days for an observation period,Six cycles)of local advanced nasopharyngeal carcinoma after Intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy(cisplatin).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

240

Start Date

July 1, 2018

Completion Date

July 28, 2021

Primary Completion Date

July 28, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with newly histologically confirmed non-keratinizing (according to WHO
             histologically type) Tumor staged as T4 or N2-3 or lymph node>3cm and M0(according to
             the 8th AJCC edition).

          2. Adequate hematological function: hemoglobin >80 g/L, neutrophil count > 1.5×10^9/L,
             platelet count 80×10^9/L.

          3. Adequate liver function (serum transminase ≤ 2.5 times higher than upper
             limit),adequate renal function (creatinine clearance ≥ 60 mL/min).

          4. Karnofsky performance status (KPS) score of at least 70 or Eastern Cooperative
             Oncology Group (ECOG) performance status of 0 or 1.

          5. Patients must give signed informed consent.

        Exclusion Criteria:

          1. Other or mixed pathological type.

          2. age > 70 years.

          3. Severe heart, liver and kidney damage.

          4. History of other malignancy.

          5. Prior chemotherapy or radiation of the primary tumor.

          6. History of psychiatric disorders.

          7. Positive urine protein.

          8. A healed wound for long time or incomplete fracture.

          9. Before treatment,MRI showed that the tumor might be an important risk factor (for
             example, wrapping around the internal carotid artery / vein); or researchers judged
             that the tumor is a high risk of serious blood vessel bleeding during the treatment.

         10. Patient who has high blood pressure can not be controlled by a single antihypertensive
             drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg.

         11. Any unstable angina pectoris;with a history of angina pectoris were newly diagnosed
             with angina pectoris within 3 months before screening; any myocardial infarction
             events occurred within 6 months before screening; arrhythmia (including QTcF: male ≥
             450ms, female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function
             insufficiency ≥II according to New York Heart Association class.

         12. Medical history of arteriovenous thrombosis event within the past year, such as
             cerebral vascular accident (including transient ischemic attack) and deep venous
             thrombosis (venous catheter thrombosis caused by chemotherapy and investigator judged
             that the patient had recovered, these patients should be except) and pulmonary
             embolism.

         13. Patient who has serious hemorrhages, any serious bleeding events classification at 3
             degree or more (according to CTCAE4.0) within the last 4 weeks.

         14. Patient who has abnormal coagulation and bleeding tendency (signed informed consent
             before 14 days, and must be satisfied: INR is in the normal range without the use of
             anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua
             Falin, heparin or its analogues, with international normalized ratio (INR) is less
             than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small
             dose aspirin (total dose ≤ 100 mg daily).

         15. For females:patients should be surgical sterilization or postmenopausal patients, or
             willing to receive a medical approved contraception during treatment and 6 months
             after the end of the treatment; serum or urine pregnancy test must be negative, and
             must be non lactating period within 7 days before study; for males: patients should be
             treated with surgical sterilization or willing to receive a medical approved
             contraception during treatment and 6 months after the end of the treatment.

         16. Any factors that affect the oral drug, such as the inability to swallow, diarrhea and
             intestinal obstruction.

         17. Medical history of immunodeficiency, or other acquired, congenital immunodeficiency
             disease, or history of organ transplantation.

         18. Any serious harm to the subject's safety or evidence of significant medical illness
             that in the investigator's judgment will substantially increase the risk associated
             with the subject's participation in and completion of the study.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Wei Jiang, Ph.D., +86-773-2882906, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT03612219

Organization ID

GLMU-04

Responsible Party

Sponsor-Investigator

Study Sponsor

Wei Jiang

Collaborators

 Wuzhou Red Cross Hospital

Study Sponsor

Wei Jiang, Ph.D., Study Director, Guilin Medical University, China

Verification Date

July 2018