A Single Arm,Open Clinical Study of Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies

China International Medical Foundation1 site in 1 country30 target enrollmentOctober 16, 2018

ConditionsHead and Neck Cancer

InterventionsApatinib

DrugsApatinib

Overview

Phase: Phase 1
Intervention: Apatinib
Conditions: Head and Neck Cancer
Sponsor: China International Medical Foundation
Enrollment: 30
Locations: 1
Primary Endpoint: PFS
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.

Registry

clinicaltrials.gov

Start Date

October 16, 2018

End Date

September 1, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China International Medical Foundation

Responsible Party

Principal Investigator

Ping Liu

Attending doctor in oncology

China International Medical Foundation

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old, male or female;
•Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);
•Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;
•According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;
•ECOG PS: 0-1 points;
•Baseline blood and biochemical indicators meet the following criteria:
•Hemoglobin ≥ 80g/L, Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥ 90×109/L, ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastases), Serum total bilirubin ≤ 1.5 times the normal upper limit, Serum creatinine ≤ 1.5 times the normal upper limit, Serum albumin ≥ 30g / L;
•The expected survival period is ≥3 months;
•Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
•Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.

Exclusion Criteria

•A person who has been confirmed to be allergic to apatinib and/or its excipients;
•Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male \> 450 ms, female \> 470 ms) and grade I cardiac insufficiency; urine protein positive patients;
•Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
•Patients who have used apatinib or tigeo in the first line
•abnormal blood coagulation (INR\>1.5, APTT\>1.5 ULN), with bleeding tendency;
•Patients with central nervous system metastases;
•Pregnant or lactating women;
•Patients with other malignancies within 5 years;
•Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
•Patients who have participated in other drug clinical trials within 4 weeks;