Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT03654612
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03654612
Study Brief:
Protocol Section:
NCT03654612