Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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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; Have received VEGFR inhibitors such as sorafenib and sunitinib; According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study; The investigator believes that it is not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib+S-1<br>Patients with recurrent/metastatic head and neck malignancies received apatinib plus S-1 as second-line therapy. | Drug: Apatinib<br>* Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle<br>* Other names: S-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 40 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 40 months |