NCT05717764

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

A Randomized, Open-label, Positive-controlled, Multicenter Phase Ш Study Comparing Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Therapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Metastatic Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone hydrochloride liposome injection	Mitoxantrone hydrochloride liposome injection will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
DRUG	Capecitabine	Capecitabine will be administered orally in a 3-week treatment cycle, twice a day from day 1 to day 14 of each cycle.

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2023-02-08
• Last updated: 2023-02-08