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.
Five hundred patients with recurrent metastatic nasopharyngeal carcinoma will be randomly assigned to the experimental group or the control group. The experimental group will receive mitoxantrone hydrochloride liposome injection combined with capecitabine, and the control group will receive capecitabine alone. All patients will be treated until disease progression as determined by the investigator based on RECIST 1.1 criteria, intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Mitoxantrone hydrochloride liposome injection will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Capecitabine 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
Time frame: Throughout the study period, up to approximately 2 years
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.
Time frame: Throughout the study period, up to approximately 2 years
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
Time frame: Throughout the study period, up to approximately 2 years
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
Time frame: Throughout the study period, up to approximately 2 years
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
Time frame: Throughout the study period, up to approximately 2 years
Progression-free survival (PFS) assessed by the investigator
Progression-Free Survival PFS is defined as the time from randomization to progression or death
Time frame: Throughout the study period, up to approximately 2 years
Frequency and severity of AE (NCI CTCAE 5.0)
Time frame: Throughout the study period, up to approximately 2 years
Blood concentrations of total and free mitoxantrone
Time frame: At the end of Cycle 4 (each cycle is 28 days)
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