apatinib combined with s-1 for the treatment of recurrent/metastatic head and neck malignancies

Conditions: Head and Neck Cancer

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.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, male or female; 2. pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral ct scan ≥10mm, meeting recist 1.1 criteria); 3. late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy; 4. according to ctcae 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy; 5. ecog ps: 0-1 points; 6. 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; 7. the expected survival period is ≥3 months; 8. 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. 9. subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up. exclusion criteria: 1. a person who has been confirmed to be allergic to apatinib and/or its excipients; 2. 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; 3. have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 4. patients who have used apatinib or tigeo in the first line 5. abnormal blood coagulation (inr\>1.5, aptt\>1.5 uln), with bleeding tendency; 6. patients with central nervous system metastases; 7. pregnant or lactating women; 8. patients with other malignancies within 5 years; 9. patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 10. patients who have participated in other drug clinical trials within 4 weeks; 11. have received vegfr inhibitors such as sorafenib and sunitinib; 12. 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; 13. the investigator believes that it is not suitable for inclusion.