RecruitingPhase 2NCT06472713

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


Sponsor

Ming-Yuan Chen

Enrollment

32 participants

Start Date

Jul 20, 2024

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new chemotherapy drug (mitoxantrone hydrochloride liposome) combined with another cancer drug (famitinib) for people with nasopharyngeal carcinoma (a type of cancer at the back of the nose/throat) that has come back or spread after prior treatment, including treatment with immunotherapy drugs. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with nasopharyngeal carcinoma confirmed by tissue biopsy - Your cancer has come back or spread and has stopped responding to prior treatment including immunotherapy - You are generally healthy enough to carry out daily activities - Your liver, kidneys, blood counts, and heart are functioning adequately **You may NOT be eligible if...** - Your cancer could still be surgically removed - You are allergic to liposomal drugs or the study drugs - You have received high cumulative doses of certain heart-affecting chemotherapy drugs - You have uncontrolled high blood pressure or significant heart disease - You are pregnant or breastfeeding - You have HIV, active Hepatitis B or C - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMitoxantrone 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.

DRUGPD-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

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NCT06472713


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