NCT06472713

Clinical Study of Mitoxantrone Hydrochloride Liposome Combined with PD-1 Blockade in Recurrent or Metastatic NPC

A Prospective, Single-arm Phase 2 Study Evaluating the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection Combined with PD-1 Blockade in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Ming-Yuan Chen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with PD-1 blockade in patients with recurrent (not unable to locally curative treatment) or metastatic NPC who failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1.

Detailed description

Thirty-two recurrent (not unable to locally curative treatment) or metastatic NPC patients who had failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1 were eligible to receive mitoxantrone hydrochloride liposome injection combined with PD-1 blockade once every 3 weeks for up to 8 cycles, following PD-1 blockade alone once every 3 weeks for 2 years. 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 evaluate the efficacy and safety of the treatment regimen.

Conditions

• Recurrent or Metastatic Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone hydrochloride liposome injection	Mitoxantrone hydrochloride liposome injection once every 3 weeks for up to 8 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.
DRUG	PD-1 Inhibitors	PD-1 blockade (comprising tislelizumab \<200 mg/cycle\>, carrellimab \<200 mg/cycle\>, or toripalimab \<240 mg/cycle\>) once every 3 weeks for two years, or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

Timeline

• Start date: 2024-07-20
• Primary completion: 2025-10-31
• Completion: 2027-09-30
• First posted: 2024-06-25
• Last updated: 2025-01-13

Locations

1 site across 1 country: China