This is a randomized, open-label, positive-controlled, multicenter Phase Ш study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in patients with recurrent metastatic nasopharyngeal carcinoma.
Willing to participate in the study and sign the informed consent form (ICF).
Age ≥ 18 years.
Nasopharyngeal carcinoma confirmed by histopathology.
Recurrent metastatic nasopharyngeal carcinoma that has previously failed treatment with first-line platinum-containing standard regimens and/or second-line standard regimens.
Severe allergy to mitoxantrone or liposome; Previous severe, unexpected reactions to fluorouracil or known allergy to fluorouracil or to any excipients of capecitabine.
Previous treatment regimens containing capecitabine for recurrent or metastatic nasopharyngeal carcinoma; Patients with locally advanced nasopharyngeal carcinoma have previously experienced disease recurrence or metastasis during or within 6 months of use of capecitabine.
Patients with brain or meningeal metastasis.
Expected lifetime < 3 months.
Parallel
Mitoxantrone hydrochloride liposome injection
DrugMitoxantrone hydrochloride liposome injection will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Capecitabine
DrugCapecitabine will be administered orally in a 3-week treatment cycle, twice a day from day 1 to day 14 of each cycle.
Progression-free survival (PFS) assessed by the independent review committee (IRC)
Progression-Free Survival PFS is defined as the time from randomization to progression or death
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Objective response rate (ORR) assessed by the investigator and IRC
Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment
Disease control rate (DCR) assessed by the investigator and IRC
Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents
Duration of Response (DOR) assessed by the investigator and IRC
Duration of Response (DOR) is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death
Progression-free survival (PFS) assessed by the investigator
Progression-Free Survival PFS is defined as the time from randomization to progression or death
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This trial is not recruiting at the moment. You can still explore other options:
