Clinical trial NCT03654612: Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
Official title: A Single Arm,Open Clinical Study of Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: China International Medical Foundation
Sponsor class: OTHER
Collaborators: name: Chinese Society of Clinical Oncology
First posted: 2018-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: PFS
timeFrame: 40 months
Secondary outcomes:
measure: OS
timeFrame: 40 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Second Xiangya Hospital
state: Hunan
Study officials:
References: