Actively Recruiting
A Phase 2 Study of Mitoxantrone Hydrochloride Liposome Injection Combined with PD-1 Blockade in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma
Led by Ming-Yuan Chen · Updated on 2025-01-13
32
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining mitoxantrone hydrochloride liposome injection with PD-1 blockade in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have not responded to at least one first-line platinum-based treatment and/or anti PD-1/L1 therapy. This Phase 2, single-arm study includes patients with recurrent NPC that cannot be treated locally or metastatic disease, focusing on those who have failed previous standard treatments. Participants will receive mitoxantrone hydrochloride liposome injection at a dose of 30 mg every 3 weeks for up to 8 cycles. This treatment is combined with PD-1 blockade using one of several drugs (tislelizumab, carrellimab, or toripalimab) administered every 3 weeks for two years or until certain conditions occur, such as disease progression or unacceptable side effects. After completing the combination treatment cycles, patients continue with PD-1 blockade alone on the same schedule for up to two years. Throughout the study, patients will have regular visits and imaging tests to assess treatment response and safety. Researchers will monitor outcomes such as the objective response rate, duration of response, disease control rate, progression-free survival, and overall survival over an average of two years. Treatment will continue until progression, toxicity, withdrawal, or other specified endpoints. The total participation duration depends on each patient's response and tolerance to the study drugs.
CONDITIONS
Brief Title
Clinical Study of Mitoxantrone Hydrochloride Liposome Combined with PD-1 Blockade in Recurrent or Metastatic NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign informed consent
- Histopathological confirmation of nasopharyngeal carcinoma (differentiated or undifferentiated non-keratinous carcinoma)
- Age between 18 and 70 years
- Performance Status score of 0-1
- Recurrent or metastatic NPC that failed first-line platinum-containing and/or second-line standard regimen
- Previously received at least one line of systemic therapy
- Failed anti PD-1/L1 therapy with specific relapse or progression criteria
- At least one measurable lesion per RECIST 1.1 criteria
- Acute toxicities from prior therapy resolved to grade 1 or less
- Adequate hematologic, liver, kidney, and proteinuria function as specified
- Expected survival of at least 3 months
- Female participants with negative pregnancy test and effective contraception if of reproductive potential
- Male participants and partners agree to use effective contraception
You will not qualify if you...
- Recurrent lesions suitable for radical local surgery
- Severe allergy to mitoxantrone or liposome
- Prior anthracycline treatment exceeding cumulative dose limits
- Estimated survival less than 3 months
- Other malignancies within 5 years except certain treated cancers
- Recent antitumor treatment within 4 weeks before enrollment
- Uncontrolled hypertension or significant heart disease
- Severe infection or unexplained fever prior to treatment
- Use of immunosuppressants or systemic steroids above specified doses
- Active or history of autoimmune diseases requiring intervention
- Recent severe respiratory disease or active tuberculosis
- HIV positive or active hepatitis B or C infection
- Recent live vaccine administration
- Pregnant or lactating women
- Unwillingness or inability to use contraception
- Serious uncontrolled medical or psychiatric conditions
- Other investigator-determined reasons inappropriate for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or other reasons
Participants receive mitoxantrone hydrochloride liposome injection combined with PD-1 blockade once every 3 weeks for up to 8 cycles, followed by PD-1 blockade alone once every 3 weeks for up to two years or until disease progression, intolerable toxicity, withdrawal, or other reasons.
Visits every 3 weeks during treatment cycles
Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
Research Team
M
Mingyuan Chen, Doctor
J
Jijin Yao, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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