Head and Neck Cancer
Conditions
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.
Interventions
DRUGApatinib
Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle
Sponsors
Chinese Society of Clinical Oncology
China International Medical Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 40 months | Progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 40 months | Overall survival |
Countries
China
Contacts
Primary ContactLiu Ping, doctor
Backup ContactLiu Bin, doctor
Outcome results
None listed