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:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT04902027
Eligibility Criteria:
Inclusion Criteria:
1. Subjects fully understand and voluntarily participate in this study and sign informed consent;
2. . Age ≥18, female or male;
3. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
4. Fail to respond to or progressed on at least one line of the standard therapy;
5. At least one measurable lesion according to RECIST v1.1;
6. ECOG performance status of 0 to 1;
7. AEs from the previous treatment have resolved to ≤ Grade 1 based on
Exclusion Criteria:
1. History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
2. Untreated or symptomatic central nervous system (CNS) metastases;
3. History of allotransplantation;
4. Life expectancy \< 3 months
5. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
6. Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
7. Use of other anticancer treatment within 4 weeks prior to the first dose administration;
8. Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
9. Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
10. Thrombosis or thromboembolism within 6 months prior to screening;
11. History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
12. Impaired cardiac function or serious cardiac disease
13. Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is \>350 mg/m2
14. Pregnant or lactating female;
15. Serious and/or uncontrolled systemic diseases;
16. Not suitable for this study as decided by the investigator due to other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04902027
Study Brief:
Protocol Section:
NCT04902027