Recurrent or Metastatic Nasopharyngeal CarcinomaPhase 2NCT06472713
Clinical Study of Mitoxantrone Hydrochloride Liposome Combined with PD-1 Blockade in Recurrent or Metastatic NPC
A Phase 2 study testing Mitoxantrone hydrochloride liposome injection and PD-1 Inhibitors in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by Ming-Yuan Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent or Metastatic Nasopharyngeal Carcinoma
- What is being tested?
- Mitoxantrone hydrochloride liposome injection and PD-1 Inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in the study, sign the informed consent form (ICF), and comply with study plan visits, treatment plans, laboratory tests, and other study procedures.
- Nasopharyngeal carcinoma confirmed by histopathology (differentiated or undifferentiated non-keratinous carcinoma).
- Age ≥ 18 \& ≤ 70 years.
- PS (Performance Status) score 0-1.
- Recurrent or metastatic nasopharyngeal carcinoma that has failed first-line platinum-containing standard regimen and/or second-line standard regimen failure.
- Previously received at least one line of systemic therapy. (Progression after radical concurrent chemoradiotherapy, during neoadjuvant or adjuvant therapy, or within 6 months after the end of treatment can be recorded as 1-line therapy).
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- Recurrent or metastatic nasopharyngeal carcinoma that has failed anti PD-1/L1: anti PD-1/L1 exposure at least 6 weeks, and the protocol used at the time of enrollment in this study meets one of the following two points: (1) Relapse during adjuvant therapy after radiotherapy, or relapse within 6 months after the end of treatment; (2) First-line treatment phase, progression during anti PD-1/L1 treatment, or progression within 3 months after the end of anti PD-1/L1 (whether combined with chemotherapy/targeting drugs);
- At least one measurable lesion according to RECIST 1.1 criteria (the spiral CT scan diameter of the measurable lesion is ≥ 10 mm or the short diameter of the enlarged lymph node is ≥15mm ); lesions that have undergone local treatment can be selected as target lesions if there is clear evidence of significant progress compared to the end of treatment.
- All acute toxicities of previous antitumor therapy have returned to ≤ grade 1 (according to NCI-CTCAE v5.0) or reached the level specified in the inclusion/exclusion criteria. (Except for partial toxicity, such as alopecia, hair color change, nail change, fatigue, etc., which do not pose safety risks to subjects).
- Adequate main organ function. a. Hematology: neutrophil absolute value (ANC) ≥1.5×10^9/L, hemoglobin (Hb) ≥ 9.0 g/dL, platelets ≥ 100×10^9/L; b. Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN could be enrolled; patients with liver metastasis, ≤ 5 times ULN), AST and ALT ≤ 3 times ULN, and alkaline phosphatase ≤ 3 times ULN; Albumin ≥ 3 g/dL; c. International Normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times; d. Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault formula; e. Proteinuria: urinary protein/creatinine ratio (UPC ratio) < 1.0. If the UPC ratio is less than or equal to 0.5, no further check is required. Patients with UPC ratio > 0.5 and those with 24-hour urinary protein < 1000 mg could be enrolled; f. Note: The UPC ratio of random urine is a quantitative estimate of 24-hour urinary protein, and the two have a good correlation. UPC ratio can be calculated using the following formula: (a) Urinary protein/urinary creatinine (if both protein and creatinine are mg/dL); (b) (urinary protein)*0.088/ urinary creatinine (if urinary creatinine is mmol/L).
- Survival is expected to be ≥ 3 months.
- Female subjects with negative blood human chorionic gonadotropin (HCG) (except for menopause and hysterectomy), female subjects of reproductive age and their partners using effective contraception during the trial period and within 6 months after the end of the last dose (e.g. Combined hormones [containing estrogen and progesterone combined to inhibit ovulation, progesterone contraception combined to inhibit ovulation, IUD, intrauterine hormone release system, bilateral tubal ligation, vasectomy, abstinence from sex, etc.).
- Male patients and their partners agree to use one of the contraceptive measures described in Article 9.
Who cannot join
- Recurrent lesions in local areas suitable for radical method (surgery) treatment.
- Severe allergy to mitoxantrone or liposome (such as systemic rash/erythema hypotension, bronchospasm, angioedema, or anaphylaxis).
- Prior treatment with doxorubicin or other anthracyclines and the cumulative doxorubicin doses greater than 350 mg/m^2 (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mg mitoxantrone).
- Estimated survival < 3 months.
- Diagnosed and/or treated with other malignancies within 5 years prior to initial administration. (except for cervical cancer, skin basal cell or squamous cell carcinoma, localized prostate cancer, and ductal carcinoma in situ after radical treatment).
- Received surgery, chemotherapy, radiotherapy, immunotherapy, or any investigational drug or other antitumor therapy within the 4 weeks prior to initial administration (less than 2 weeks after palliative radiotherapy).
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- Patients with hypertension who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure > 140 mmHg/ diastolic blood pressure > 90 mmHg); Have ≥ grade II coronary heart disease; Any of the following conditions occurred during the first 6 months of enrollment: Myocardial infarction, severe/unstable angina pectoris, NYHAII grade or higher cardiac insufficiency, grade 2 or higher persistent arrhythmias (including prolonged QTc interval > 450ms in men), Women > 470ms), any grade of atrial fibrillation, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); The ejection fraction of the heart is below 50% or below the lower limit of the range of laboratory tests at the study center. Patients with a history of arterial thromboembolism events and venous thromboembolism > grade 3. (Patients with S-T elevation ≥ 2mm on the ECG may be enrolled if they do not show signs of recent myocardial infarction or ischemia) (according to NCI-CTCAE v5.0).
- Severe infection (such as intravenous antibiotics, antifungals, or antivirals as required by clinical practice) during the 4 weeks prior to the first dose, or any unexplained fever >38.5 ° C during the screening period / 7 days prior to the first dose, or white blood cell count >15×109/L at baseline.
- Immunosuppressants, or systemic hormone therapy (dose >10mg/ day of prednisone or other therapeutic hormone) are being used for the purpose and continue to be used within 2 weeks before the first dose.
- The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention as adults were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
- Exacerbations of COPD or other respiratory diseases requiring hospitalization within 1 month prior to registration.Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening.
- HIV-positive people; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥1000 cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive).
- Live vaccine was administered within 4 weeks before the first dose or possibly during the study period.
- Pregnant or lactating women.
- Women with reproductive potential and sexually active men who are unwilling/unable to use medically acceptable forms of contraception.
- Have any serious and/or uncontrollable medical conditions that, as determined by the investigator, may affect the patient's participation in the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, and family or social factors that affect the safety of the patient.
- Other situations that the investigator determines to be inappropriate for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, 519000
Tian Xin Lin, PhD, 86-0756-2528100, cheny778@mail.sysu.edu.cn
Ming Yuan Chen, PhD
About this study
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
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.
Read the detailed description
Thirty-two recurrent (not unable to locally curative treatment) or metastatic NPC patients who had failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1 were eligible to receive mitoxantrone hydrochloride liposome injection combined with PD-1 blockade once every 3 weeks for up to 8 cycles, following PD-1 blockade alone once every 3 weeks for 2 years. All patients will be treated until disease progression as determined by the investigator based on RECIST 1.1 criteria, intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. Regular visits and imaging examinations will be conducted to evaluate the efficacy and safety of the treatment regimen.
- Being tested
- Mitoxantrone hydrochloride liposome injection, PD-1 Inhibitors
- Keywords
- Nasopharyngeal Carcinoma, Recurrent, Metastatic, Mitoxantrone Hydrochloride Liposome, PD-1 Blockade
- Medical subject headings
- Recurrence, Nasopharyngeal Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone hydrochloride liposome injectionDrug
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.
PD-1 InhibitorsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone group | Experimental | Mitoxantrone hydrochloride liposome (30 mg/cycle) injection combined with PD-1 blockade (comprising tislelizumab <200 mg/cycle>, carrellimab <200 mg/cycle>, or toripalimab <240 mg/cycle>) once every 3 weeks for up to 8 cycles, following the uniform PD-1 blockade alone once every 3 weeks for two years, or until intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first. Receives: Drug: Mitoxantrone hydrochloride liposome injection; Drug: PD-1 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Duration of Response (DOR)
Duration of Response (DOR) is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death
Measured: Through study completion, an average of 2 years
Disease control rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents
Measured: Through study completion, an average of 2 years
Progression-free survival (PFS)
Progression-Free Survival PFS is defined as the time from randomization to progression or death
Measured: Through study completion, an average of 2 years
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start20 Jul 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming-Yuan Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472713
- Sponsor's protocol ID
- ZDWY.BYAFZZX.027
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be requested from the corresponding author beginning 1 year after publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06472713
- Acronym / sponsor ID
- ZDWY.BYAFZZX.027
- Keywords
- Nasopharyngeal Carcinoma, Recurrent, Metastatic, Mitoxantrone Hydrochloride Liposome, PD-1 Blockade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thirty-two recurrent (not unable to locally curative treatment) or metastatic NPC patients who had failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1 were eligible to receive mitoxantrone hydrochloride liposome injection combined with PD-1 blockade once every 3 weeks for up to 8 cycles, following PD-1 blockade alone once every 3 weeks for 2 years. All patients will be treated until disease progression as determined by the investigator based on RECIST 1.1 criteria, intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. Regular visits and imaging examinations will be conducted to evaluate the efficacy and safety of the treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone group | Experimental | Drug: Mitoxantrone hydrochloride liposome injection, Drug: PD-1 InhibitorsMitoxantrone hydrochloride liposome (30 mg/cycle) injection combined with PD-1 blockade (comprising tislelizumab <200 mg/cycle>, carrellimab <200 mg/cycle>, or toripalimab <240 mg/cycle>) once every 3 weeks for up to 8 cycles, following the uniform PD-1 blockade alone once every 3 weeks for two years, or until intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing to participate in the study, sign the informed consent form (ICF), and comply with study plan visits, treatment plans, laboratory tests, and other study procedures.
- Nasopharyngeal carcinoma confirmed by histopathology (differentiated or undifferentiated non-keratinous carcinoma).
- Age ≥ 18 \& ≤ 70 years.
- PS (Performance Status) score 0-1.
- Recurrent or metastatic nasopharyngeal carcinoma that has failed first-line platinum-containing standard regimen and/or second-line standard regimen failure.
Key exclusion criteria (17 listed)
- Recurrent lesions in local areas suitable for radical method (surgery) treatment.
- Severe allergy to mitoxantrone or liposome (such as systemic rash/erythema hypotension, bronchospasm, angioedema, or anaphylaxis).
- Prior treatment with doxorubicin or other anthracyclines and the cumulative doxorubicin doses greater than 350 mg/m^2 (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mg mitoxantrone).
- Estimated survival < 3 months.
- Diagnosed and/or treated with other malignancies within 5 years prior to initial administration. (except for cervical cancer, skin basal cell or squamous cell carcinoma, localized prostate cancer, and ductal carcinoma in situ after radical treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone hydrochloride liposome injectionMitoxantrone 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 | Mitoxantrone group |
| PD-1 InhibitorsPD-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. | Drug | Mitoxantrone group |
Primary outcome
Objective response rate (ORR)
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment
4 secondary outcomes
Duration of Response (DOR)
Time frame: Through study completion, an average of 2 years
Disease control rate (DCR)
Time frame: Through study completion, an average of 2 years
Progression-free survival (PFS)
Time frame: Through study completion, an average of 2 years
Overall survival (OS)
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No. Data can be requested from the corresponding author beginning 1 year after publication of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone hydrochloride liposome injection and PD-1 Inhibitors in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by Ming-Yuan Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingyuan Chen, Doctor (18124188280, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.