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
Ming-Yuan Chen
32 participants
Jul 20, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
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.
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.
Locations(1)
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NCT06472713