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RECRUITING
NCT06472713
PHASE2

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

Sponsor: Ming-Yuan Chen

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-07-20

Completion Date

2027-09-30

Last Updated

2025-01-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, Guangdong, China