Recurrent or Metastatic Nasopharyngeal CarcinomaPhase 2NCT07070479
Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial
A Phase 2 study testing Ivonescimab, Nimotuzumab and Irinotecan liposome in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by Ming-Yuan Chen at 6 sites in China.
Trial summary
This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior 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?
- Ivonescimab, Nimotuzumab and Irinotecan liposome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 6 sitesChina
- Study dates
- 24 Jun 2025to 30 Jan 2028
- 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
- Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undifferentiated subtype, corresponding to WHO type II or III).
- Age between 18 and 70 years.
- Performance Status (PS) score of 0 or 1.
- Disease progression after prior platinum-based doublet chemotherapy.
- Received at least one line of systemic therapy previously. (Progression occurring during or within 6 months after definitive concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy, or treatment completion may be counted as first-line treatment.)
- Resistance to anti-PD-1 antibody therapy (either combination or sequential), including primary or secondary resistance（PD-1 exposure must be at least 6 weeks.）
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- At least one measurable lesion according to RECIST 1.1 criteria.
- All acute toxicities from prior anti-tumor therapies have resolved to grade ≤1 (per NCI-CTCAE v5.0) or meet the specified inclusion/exclusion thresholds. (Certain toxicities such as alopecia, hair color changes, nail changes, fatigue, etc., which do not pose safety risks, are exempt.)
- Adequate organ function:
- Hematology: WBC ≥ 4000/μL, absolute neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL.
- Liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with Gilbert's syndrome and bilirubin ≤ 3 × ULN are eligible); AST and ALT ≤ 3 × ULN; alkaline phosphatase ≤ 3 × ULN; albumin ≥ 3 g/dL.
- Coagulation: INR, prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min calculated by Cockcroft-Gault formula. Proteinuria: Urine protein/creatinine ratio (UPC) < 1.0. For UPC ≤ 0.5, no further testing is required; for UPC > 0.5, 24-hour urine protein must be < 1000 mg for eligibility.
- Estimated life expectancy of at least 3 months.
- Signed informed consent and willingness and ability to comply with study visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Locoregional recurrent lesions that are amenable to definitive (curative) treatment, such as surgery.
- Prior treatment with any regimen included in the study protocol.
- Prior use of agents targeting the VEGF or VEGFR pathway.
- Diagnosis and/or treatment of another malignancy within the past 5 years, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ.
- Receipt of surgery, chemotherapy, radiotherapy, immunotherapy, any investigational agent, or other anti-cancer therapy within 4 weeks prior to enrollment (or within 2 weeks for palliative radiotherapy).
- Tumor encasement of the internal carotid artery or evidence of nasopharyngeal necrosis observed on endoscopy prior to enrollment.
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- Any significant bleeding event (≥ Grade 2, CTCAE v5.0) within 4 weeks prior to enrollment, or visible hemoptysis defined as ≥ 1/2 teaspoon of fresh red blood or blood clots with little or no sputum. Recurrent positive fecal occult blood test (++ or more) during screening also leads to exclusion. (Patients with occasional blood-tinged sputum may be eligible.)
- Active peptic ulcers or gastrointestinal surgery within 1 month prior to enrollment; history within 6 months of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal hemorrhage, esophageal varices, or pathological fracture.
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg) despite antihypertensive therapy; coronary artery disease ≥ Grade II; or any of the following within 6 months prior to enrollment: myocardial infarction, severe or unstable angina, NYHA class II or higher heart failure, sustained arrhythmia ≥ Grade 2 (including QTc >450 ms in males or >470 ms in females), atrial fibrillation of any grade, coronary or peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular events (e.g., TIA or symptomatic pulmonary embolism). History of arterial thromboembolism or venous thromboembolism > Grade 3. (ST elevation ≥2 mm on ECG without clinical evidence of myocardial infarction or ischemia is not exclusionary.)
- History of bleeding diathesis, hemorrhagic disorders, or coagulopathy; current use of anticoagulants or antiplatelet agents including warfarin, heparin, aspirin >325 mg/day, ticlopidine, clopidogrel, or cilostazol, unless discontinued ≥10 days prior to first dose and coagulation parameters meet inclusion criteria.
- Severe infection requiring intravenous antibiotics, antifungals, or antivirals within 4 weeks prior to the first dose, or unexplained fever >38.5°C within 7 days prior to the first dose; baseline WBC >15 × 10⁹/L.
- Known hypersensitivity to study drugs or excipients, or a history of severe hypersensitivity reactions such as generalized rash/erythema, hypotension, bronchospasm, angioedema, or anaphylaxis.
- Conditions that may affect oral drug absorption, including dysphagia, nausea/vomiting, chronic diarrhea, or bowel obstruction.
- Ongoing treatment with immunosuppressants or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose.
- Presence of any active autoimmune disease or a history of autoimmune diseases likely to recur (including but not limited to interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions include vitiligo and childhood asthma now in complete remission. Patients with asthma requiring bronchodilator therapy are excluded.
- History of acute exacerbation of chronic obstructive pulmonary disease or other respiratory disease requiring hospitalization within 1 month prior to enrollment; patients with active tuberculosis or those who received anti-TB therapy within 1 year prior to screening.
- HIV positive; or positive HBsAg with quantifiable HBV DNA ≥1000 cps/mL; or positive anti-HCV antibody.
- Receipt of live vaccines within 4 weeks prior to first dose or anticipated during the study period.
- Positive pregnancy test or currently breastfeeding.
- Women of childbearing potential or sexually active men who are unwilling or unable to use medically accepted methods of contraception during the study period.
- Any condition, as determined by the investigator, that may interfere with the study results or patient safety, such as substance abuse, serious physical or mental illness requiring concurrent treatment, significant laboratory abnormalities, or adverse social/family circumstances.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Yuxiang He, +86 13786112914
- Not yet recruiting
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong
Bin Qi, +86 13580580985
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yi Pan, +86 13719188887
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Peiyu Huang, +86 13632396200
- Not yet recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong
Feng Lei, +86 13528227676
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong
Mingyuan Chen, +86 18124188280, chmingy@mail.sysu.edu.cn
About this study
Official title: A Bayesian Adaptive Phase II Randomized Trial Comparing Ivonescimab, Ivonescimab Plus Nimotuzumab, Liposomal Mitoxantrone Plus Anti-PD-1 Antibody, and Liposomal Irinotecan Plus S-1 in Patients With PD-1-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy.
The four treatment arms include:
- Ivonescimab monotherapy,
- Ivonescimab combined with nimotuzumab,
- Liposomal mitoxantrone plus anti-PD-1 antibody, and
- Liposomal irinotecan plus S-1.
Read the detailed description
Patients with recurrent (not amenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have progressed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy are eligible for this study. This trial adopts a Bayesian Adaptive Randomization with Constant Power parameter (BARCP) design. The planned maximum sample size is 208 patients, with a minimum of 32 patients to be enrolled before potential early termination for futility or efficacy based on interim analysis.
The first 40 patients will be randomized with equal probability to one of the four treatment arms:
- Ivonescimab monotherapy
- Ivonescimab combined with nimotuzumab
- Liposomal mitoxantrone plus an anti-PD-1 antibody
- Liposomal irinotecan plus S-1
Subsequent randomization probabilities will be updated based on objective response rate (ORR) using interim analyses, which will include decisions for early efficacy, futility, or reassignment of allocation probabilities for future participants. Interim analyses will be conducted every time 16 new patients complete ORR assessment. The minimum allocation probability for each treatment arm is constrained to 5%.
All patients will receive treatment until disease progression (as determined by the investigator based on RECIST 1.1 criteria), intolerable toxicity, withdrawal of informed consent, initiation of new anticancer therapy, loss to follow-up, death, or study completion-whichever occurs first. Regular visits and imaging assessments will be conducted to evaluate the efficacy and safety of the treatment regimens.
- Being tested
- Ivonescimab, Nimotuzumab, Irinotecan liposome, S-1, Mitoxantrone Hydrochloride Liposome
- Keywords
- nasopharyngeal carcinoma, Recurrent, metastatic, PD-1 resistance, Bayesian adaptive design, Ivonescimab, Nimotuzumab, Liposomal mitoxantrone, Liposomal irinotecan, S-1
- 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.
IvonescimabDrug
Ivonescimab 10 mg/kg via intravenous infusion, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.
NimotuzumabDrug
Nimotuzumab 400 mg via intravenous infusion, Q3W, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.
Irinotecan liposomeDrug
Irinotecan liposome 50mg/m2 via intravenous infusion, D1, D15, Q4W for up to 6 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.
S-1Drug
S-1, D1-D14, BID, p.o., (BSA < 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA < 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose), Q4W for up to 6 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.
Mitoxantrone Hydrochloride LiposomeDrug
Mitoxantrone hydrochloride liposome 20mg/m2 via intravenous infusion, Q3W 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>) , Q3W 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 |
|---|---|---|
| Ivonescimab Monotherapy | Experimental | Participants will receive Ivonescimab at a dose of 10 mg/kg via intravenous infusion, Q3W. Treatment will continue until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. Receives: Drug: Ivonescimab |
| Ivonescimab plus Nimotuzumab | Experimental | Participants will receive Ivonescimab at a dose of 10 mg/kg via intravenous infusion, combined with Nimotuzumab 400 mg via intravenous infusion, Q3W.
Treatment will continue until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. Receives: Drug: Ivonescimab; Drug: Nimotuzumab |
| Mitoxantrone Plus PD-1 Inhibitor | Experimental | Participants will receive mitoxantrone hydrochloride liposome at 20 mg/m² via intravenous infusion, combined with a PD-1 inhibitor - either tislelizumab (200 mg/cycle), camrelizumab (200 mg/cycle), or toripalimab (240 mg/cycle) - Q3W, for up to 8 cycles.
After combination therapy, participants will continue receiving PD-1 blockade monotherapy every 3 weeks for up to 2 years, or until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. Receives: Drug: Mitoxantrone Hydrochloride Liposome; Drug: PD-1 Inhibitors |
| Irinotecan plus S-1 | Experimental | Participants will receive liposomal irinotecan at 50 mg/m² via intravenous infusion on D1 and D15, Q4W, in combination with oral S-1 administered BID on D 1-14 of each cycle, for up to 6 cycles.
The dose of S-1 is based on body surface area (BSA). BSA < 1.25 m²: 40 mg per dose ; 1.25 m² ≤ BSA < 1.5 m²: 50 mg per dose; BSA ≥ 1.5 m²: 60 mg per dose Treatment will continue until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. Receives: Drug: Irinotecan liposome; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1
Measured: 1 year
Secondary outcomes (7)
Progression-free Survival (PFS)
PFS is defined as the time interval from randomization to the observation of disease progression or death from any cause
Measured: 1 year
Overall Survival (OS)
OS is defined as the time interval from randomization to death from any cause
Measured: 1 year
Duration of Response (DOR)
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: 1 year
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved CR, PR and SD to a therapeutic intervention
Measured: 1 year
Adverse Events Reporting
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 1 year
Health-related Quality of Life
Changes from baseline in patient-reported quality of life scores assessed every 2 cycles using the EORTC QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, version C30). The scores range from 0 to 100, with higher scores indicating a better quality of life outcome.
Measured: 1 year
Head and Neck Cancer-Specific Quality of Life
Changes from baseline in head and neck cancer-specific symptoms and functions assessed every 2 cycles using the EORTC QLQ-H\&N35 module (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Head and Neck Cancer Module). The scores range from 0 to 100, with higher scores indicating a better quality of life outcome and lower scores indicating worse symptoms or functions.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start24 Jun 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 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
- NCT07070479
- Sponsor's protocol ID
- ZDWY.BYAFZZX.034
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 18 Sep 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bayesian Adaptive Phase II Randomized Trial Comparing Ivonescimab, Ivonescimab Plus Nimotuzumab, Liposomal Mitoxantrone Plus Anti-PD-1 Antibody, and Liposomal Irinotecan Plus S-1 in Patients With PD-1-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07070479
- Acronym / sponsor ID
- ZDWY.BYAFZZX.034
- Keywords
- nasopharyngeal carcinoma, Recurrent, metastatic, PD-1 resistance, Bayesian adaptive design, Ivonescimab, Nimotuzumab, Liposomal mitoxantrone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 17 Jul 2025 (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, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy.
The four treatment arms include:
- Ivonescimab monotherapy,
- Ivonescimab combined with nimotuzumab,
- Liposomal mitoxantrone plus anti-PD-1 antibody, and
- Liposomal irinotecan plus S-1.
Detailed description
Patients with recurrent (not amenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have progressed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy are eligible for this study. This trial adopts a Bayesian Adaptive Randomization with Constant Power parameter (BARCP) design. The planned maximum sample size is 208 patients, with a minimum of 32 patients to be enrolled before potential early termination for futility or efficacy based on interim analysis.
The first 40 patients will be randomized with equal probability to one of the four treatment arms:
- Ivonescimab monotherapy
- Ivonescimab combined with nimotuzumab
- Liposomal mitoxantrone plus an anti-PD-1 antibody
- Liposomal irinotecan plus S-1
Subsequent randomization probabilities will be updated based on objective response rate (ORR) using interim analyses, which will include decisions for early efficacy, futility, or reassignment of allocation probabilities for future participants. Interim analyses will be conducted every time 16 new patients complete ORR assessment. The minimum allocation probability for each treatment arm is constrained to 5%.
All patients will receive treatment until disease progression (as determined by the investigator based on RECIST 1.1 criteria), intolerable toxicity, withdrawal of informed consent, initiation of new anticancer therapy, loss to follow-up, death, or study completion-whichever occurs first. Regular visits and imaging assessments will be conducted to evaluate the efficacy and safety of the treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab Monotherapy | Experimental | Drug: IvonescimabParticipants will receive Ivonescimab at a dose of 10 mg/kg via intravenous infusion, Q3W. Treatment will continue until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. |
| Ivonescimab plus Nimotuzumab | Experimental | Drug: Ivonescimab, Drug: NimotuzumabParticipants will receive Ivonescimab at a dose of 10 mg/kg via intravenous infusion, combined with Nimotuzumab 400 mg via intravenous infusion, Q3W. Treatment will continue until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. |
| Mitoxantrone Plus PD-1 Inhibitor | Experimental | Drug: Mitoxantrone Hydrochloride Liposome, Drug: PD-1 InhibitorsParticipants will receive mitoxantrone hydrochloride liposome at 20 mg/m² via intravenous infusion, combined with a PD-1 inhibitor - either tislelizumab (200 mg/cycle), camrelizumab (200 mg/cycle), or toripalimab (240 mg/cycle) - Q3W, for up to 8 cycles. After combination therapy, participants will continue receiving PD-1 blockade monotherapy every 3 weeks for up to 2 years, or until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. |
| Irinotecan plus S-1 | Experimental | Drug: Irinotecan liposome, Drug: S-1Participants will receive liposomal irinotecan at 50 mg/m² via intravenous infusion on D1 and D15, Q4W, in combination with oral S-1 administered BID on D 1-14 of each cycle, for up to 6 cycles. The dose of S-1 is based on body surface area (BSA). BSA < 1.25 m²: 40 mg per dose ; 1.25 m² ≤ BSA < 1.5 m²: 50 mg per dose; BSA ≥ 1.5 m²: 60 mg per dose Treatment will continue until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to 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 (15 listed)
- Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undifferentiated subtype, corresponding to WHO type II or III).
- Age between 18 and 70 years.
- Performance Status (PS) score of 0 or 1.
- Disease progression after prior platinum-based doublet chemotherapy.
- Received at least one line of systemic therapy previously. (Progression occurring during or within 6 months after definitive concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy, or treatment completion may be counted as first-line treatment.)
Key exclusion criteria (21 listed)
- Locoregional recurrent lesions that are amenable to definitive (curative) treatment, such as surgery.
- Prior treatment with any regimen included in the study protocol.
- Prior use of agents targeting the VEGF or VEGFR pathway.
- Diagnosis and/or treatment of another malignancy within the past 5 years, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ.
- Receipt of surgery, chemotherapy, radiotherapy, immunotherapy, any investigational agent, or other anti-cancer therapy within 4 weeks prior to enrollment (or within 2 weeks for palliative radiotherapy).
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 |
|---|---|---|
| IvonescimabIvonescimab 10 mg/kg via intravenous infusion, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. | Drug | Ivonescimab Monotherapy, Ivonescimab plus Nimotuzumab |
| NimotuzumabNimotuzumab 400 mg via intravenous infusion, Q3W, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first. | Drug | Ivonescimab plus Nimotuzumab |
| Irinotecan liposomeIrinotecan liposome 50mg/m2 via intravenous infusion, D1, D15, Q4W for up to 6 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 | Irinotecan plus S-1 |
| S-1S-1, D1-D14, BID, p.o., (BSA < 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA < 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose), Q4W for up to 6 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 | Irinotecan plus S-1 |
| Mitoxantrone Hydrochloride LiposomeMitoxantrone hydrochloride liposome 20mg/m2 via intravenous infusion, Q3W 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 Plus PD-1 Inhibitor |
| PD-1 InhibitorsPD-1 blockade (comprising tislelizumab <200 mg/cycle>, carrellimab <200 mg/cycle>, or toripalimab <240 mg/cycle>) , Q3W 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 Plus PD-1 Inhibitor |
Primary outcome
Overall Response Rate (ORR)
Time frame: 1 year
Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1
7 secondary outcomes
Progression-free Survival (PFS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Duration of Response (DOR)
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
Adverse Events Reporting
Time frame: 1 year
Health-related Quality of Life
Time frame: 1 year
Head and Neck Cancer-Specific Quality of Life
Time frame: 1year
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 18 Sep 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivonescimab, Nimotuzumab and Irinotecan liposome in people with Recurrent or Metastatic Nasopharyngeal Carcinoma, run by Ming-Yuan Chen at 6 sites 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 15 inclusion and 21 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 (+86 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?
Overall Response Rate (ORR) (time frame: 1 year). 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 18 Sep 2025.