Head and Neck Malignancies
Conditions
Interventions
Anlotinib Hydrochloride combined with Tegafur,Gimeracil and Oteracil Porassium Capsules Group:Anotinib hydrochloride capsule: 12mg Po qd, taken orally before breakfast. Continuous use for 2 weeks, dru
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years, 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 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 voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. A person who has been confirmed to be allergic to Anlotinib 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 Anlotinib or tegafur 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral blood DNA hypomethylation, VEGF, CEA,;Pathological sections HPV-DNA, MVD, HIF-1?, MVD, P53, VEGF, Survivin;OS;PFS; | — |
Countries
China
Contacts
Public ContactLiu Ping
The Second Xiangya Hospital of Central South University
Outcome results
None listed