Actively Recruiting
Study of Mitoxantrone Hydrochloride Liposome Injection Combined with PD-1 Blockade in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma A Prospective Phase 2 Single-Arm Clinical Trial
Led by Ming-Yuan Chen · Updated on 2025-01-13
32
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of combining mitoxantrone hydrochloride liposome injection with PD-1 blockade in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have not been cured by local treatment and have failed at least one prior platinum-based therapy and/or anti PD-1/L1 therapy. This is a prospective Phase 2, single-arm study involving 32 patients with recurrent or metastatic NPC. The study focuses on patients who have progressed after standard first-line treatments and/or anti PD-1/L1 therapies. Participants receive mitoxantrone hydrochloride liposome injection every three weeks for up to eight cycles or until disease progression, intolerable toxicity, withdrawal, or other specified endpoints. Concurrently, PD-1 blockade therapy (including tislelizumab, carrellimab, or toripalimab) is administered every three weeks for up to two years or until similar endpoints are met. Treatment continues until disease progression or other stopping criteria as determined by the investigator. Throughout the study, patients undergo regular visits and imaging exams to monitor treatment efficacy and safety. The main outcome measured is the objective response rate (ORR) over approximately two years. Researchers also assess toxicities, disease progression, and other health parameters until disease progression, withdrawal, death, or study completion. Overall participation may last up to two years depending on individual response and tolerance.
CONDITIONS
Official 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, sign informed consent, and comply with study procedures
- Histopathologically confirmed nasopharyngeal carcinoma (differentiated or undifferentiated non-keratinous)
- Age between 18 and 70 years
- Performance Status score of 0-1
- Recurrent or metastatic nasopharyngeal carcinoma after failure of first-line platinum-containing regimen and/or second-line standard therapy
- 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
- All acute toxicities from prior treatments resolved to grade 1 or lower (except minor toxicities without safety risk)
- Adequate organ function including hematology, liver, coagulation, renal function, and proteinuria within specified limits
- Expected survival of at least 3 months
- Females of reproductive potential and their partners must use effective contraception during and 6 months post-study
- Male patients and their partners agree to use contraception as described
You will not qualify if you...
- Recurrent lesions suitable for radical local treatment such as surgery
- Severe allergy to mitoxantrone or liposome
- Prior doxorubicin or other anthracycline treatment exceeding cumulative dose limits
- Estimated survival less than 3 months
- Other malignancies diagnosed or treated within 5 years, except certain treated cancers
- Recent anti-cancer treatments or investigational drugs within 4 weeks prior to initial administration
- Uncontrolled hypertension or significant heart diseases including recent myocardial infarction or severe arrhythmias
- Severe infection or fever over 38.5°C in the 4 weeks prior to first dose
- Use of immunosuppressants or systemic steroids above specified doses within 2 weeks before first dose
- Active or history of autoimmune diseases (with some exceptions)
- Recent exacerbations of respiratory diseases or active tuberculosis treatment
- HIV positive or active hepatitis B or C infection
- Recent live vaccine within 4 weeks before first dose or during the study
- Pregnant or lactating women
- Unwilling or unable to use medically acceptable contraception
- Serious uncontrolled medical conditions or social factors affecting safety or participation
- Other investigator-determined reasons making participation inappropriate
AI-Screening
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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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