Actively Recruiting
Clinical Study of Mitoxantrone Hydrochloride Liposome Combined with PD-1 Blockade in Recurrent or Metastatic NPC
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 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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jijin Yao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here