Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Treatment

Inclusion Criteria:

1. Willing to participate in the study and sign the informed consent form (ICF).
2. Age ≥ 18 years.
3. Nasopharyngeal carcinoma confirmed by histopathology.
4. Recurrent metastatic nasopharyngeal carcinoma that has previously failed treatmentwith first-line platinum-containing standard regimens and/or second-line standardregimens.
5. At least one evaluable lesion at baseline according to RECIST 1.1 criteria; The areashould not have received previous radiotherapy, or there is evidence that the lesionhas made definite progress after radiotherapy.
6. Eastern Cooperative Oncology Group (ECOG) score 0-1.
7. Toxic reaction caused by any previous antitumor treatment has recovered to grade 1 orbelow (except for alopecia, pigmentation, or other toxicities deemed by theinvestigator to pose no safety risk to the patient).
8. Adequate main organ function.
9. Female patients must have a negative blood HCG test (except for menopause andhysterectomy), Female patients of childbearing age and their partners must useeffective contraception (For example: combination hormones [containing estrogen andprogesterone] to suppress ovulation, progestogen contraception to suppress ovulation,intrauterine device, intrauterine hormone release system, bilateral tubal ligation,vasectomy, avoidance of sexual activity, etc) during the trial and within 6 months ofthe end of the last dose.
10. Male patients and their partners agree to use one of the contraceptive measuresdescribed in Article 9.

Exclusion Criteria:

1. Severe allergy to mitoxantrone or liposome; Previous severe, unexpected reactions tofluorouracil or known allergy to fluorouracil or to any excipients of capecitabine.
2. Previous treatment regimens containing capecitabine for recurrent or metastaticnasopharyngeal carcinoma; Patients with locally advanced nasopharyngeal carcinoma havepreviously experienced disease recurrence or metastasis during or within 6 months ofuse of capecitabine.
3. Patients with brain or meningeal metastasis.
4. Expected lifetime < 3 months.
5. Patients with active hepatitis B, hepatitis C or HIV.
6. Active bacterial infection, fungal infection, viral infection, or interstitialpneumonia requiring systemic therapy within 1 week prior to the first administrationof the study drug.
7. Antitumor therapy such as chemotherapy, small-molecule inhibitors, immunotherapy (suchas interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives (whichever isshorter but at least 2 weeks) prior to initial administration of the study drug;Received Chinese patent drugs with antitumor activity within 14 days prior toadministration.
8. Have received other investigational drugs within 4 weeks prior to initialadministration.
9. Patients had major surgery within 3 months prior to initial dosing or plan to havemajor surgery during the study period.
10. Severe embolic events, such as cerebrovascular accidents (including transient ischemicattacks) and pulmonary embolism, occurred within 6 months prior to screening.
11. Other active malignant tumors within 2 years prior to the first study drugadministration.
12. Abnormal heart function, including: Long QTc syndrome or QTc interval >480 ms; Complete left bundle branch block,second-degree or third-degree atrioventricular block; Severe, uncontrolled arrhythmiasrequiring medication; History of chronic congestive heart failure with NYHA ≥ grade 3;Cardiac ejection fraction less than 50% or lower than the lower limit of thelaboratory test range within 6 months prior to screening; CTCAE version 5.0 ≥ grade 3valvular heart disease; Uncontrolled hypertension (defined as measuring systolic bloodpressure >160 mmHg or diastolic blood pressure >90 mmHg when medically controlled);Myocardial infarction, unstable angina, history of severe pericardial disease, ECGevidence of acute ischemic or active conduction system abnormalities within 6 monthsprior to screening.
13. Prior treatment with doxorubicin or other anthracyclines and the cumulativedoxorubicin doses greater than 350 mg/m^2 (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mgmitoxantrone).
14. Pregnant or lactating women.
15. Have any serious and/or uncontrollable medical conditions that, as determined by theinvestigator, may affect the patient's participation in the study.
16. Have severe gastrointestinal disorders that affect the ingestion, transport, orabsorption of medications.
17. Other situations that the investigator determines to be inappropriate forparticipation.