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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

Efficacy and Safety of Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma: A Single-arm, Open-label, Multi-center Phase II Clinical Trial

Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma (NCT06259721) is a Phase 2 interventional studying Nasopharyngeal Carcinoma, sponsored by Jiangxi Provincial Cancer Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Nasopharyngeal Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 22 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-confirmed) with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy. If the patient refuses biopsy of metastatic lesions, those diagnosed with metastasis based on imaging evidence and clinical evidence can be enrolled. 2. Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence and metastases within 6 months after treatment of platinum-based chemoradiation. 3. Age ≥ 18 years and ≤ 75 years, both genders. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 5. The expected to live at least 3 months. 6. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria. 7. Patients must have your organs (liver, kidneys, etc.) are working well enough based on blood tests (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; blood count (hemoglobin) at least 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine \[FT3\] or free Thyroxine \[FT4\] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN. 8. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative. 9. Written willing to sign a consent form. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy. If the patient refuses biopsy of metastatic lesions, those diagnosed with metastasis based on imaging evidence and clinical evidence can be enrolled. 2. Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence and metastases within 6 months after treatment of platinum-based chemoradiation. 3. Age ≥ 18 years and ≤ 75 years, both genders. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 5. The life expectancy of at least 3 months. 6. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria. 7. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine \[FT3\] or free Thyroxine \[FT4\] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN. 8. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative. 9. Written informed consent. Exclusion Criteria: * 1\. Those with a history of severe immediate allergy to any drugs used in this study; 2. Patients who have previously received anti-EGFR monoclonal antibodies (nitolizumab, cetuximab) and anti-PD-1 monoclonal antibodies. 3\. Combined with other malignant tumors; 4. Any of the following conditions exist within 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Paroxysmal or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction \<50% must be treated with an optimized and stable medical regimen as determined by the treating physician, who may consult a cardiologist if appropriate; 5. Patients who have received any of the following treatments: (1) Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time; (2) Use of large amounts of glucocorticoids or other immunosuppressants (including but not limited to prednisone, dexamethasone, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor within 4 weeks before treatment (drugs against TNF), or subjects who require hormonal therapy during clinical trials. Other special circumstances need to be communicated with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses \>10 mg/day prednisone therapeutic dose are allowed; (4) Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of the study drug; (5) Have undergone major surgery or serious trauma within 4 weeks before using the study drug for the first time; (6) Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 6. Patients with active autoimmune diseases or a history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and can enter further screening: 1. Controlled type 1 diabetes 2. Hypothyroidism (if it can be controlled with hormone replacement therapy alone) 3. Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia) 4. Any other disease that is not expected to recur in the absence of external triggers 7. Active infections, including tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus. Patients with positive HBV surface antigen (HBsAg) but HBV DNA \<1000 copies/mL are eligible to participate in this study; patients with positive HCV antibody test results can only participate if the HCV RNA polymerase chain reaction test result is negative. Selected for this study; 8. History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (bronchiolitis obliterans), idiopathic pneumonia or evidence of active pneumonia on chest CT scan during screening; 9. No capacity for civil conduct or limited capacity for civil conduct; 10. Drug abuse or alcohol addiction, the patient has physical or mental illness, and the researcher believes that the patient cannot fully or fully understand the possible complications of this study; 11. Other serious acute or chronic medical conditions that may increase the risks related to the treatment of the research protocol, or may interfere with the interpretation of the research results and (according to the investigator's judgment) may make the patient unfit to participate in this study (including immune colitis, inflammatory colitis, Enteropathy, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including dementia and epilepsy, suicidal ideation or behavior recently, within the past year, or active) or abnormal laboratory tests; 12. Previously diagnosed with immunodeficiency or known diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 13. Pregnant or lactating female patients, male or female patients with childbearing potential but unwilling or unable to use contraception during the entire study period and for at least 1 year after the end of the treatment plan; 14. Those with recurrent nasopharyngeal carcinoma are suitable for surgical treatment.

Treatments Being Tested

DRUG

Anti-PD1 antibody, nimotuzumab and capecitabine

Combination phase Anti-PD1 monoclonal antibody: Choose one of the anti-PD-1 monoclonal antibody drugs reimbursed by medical insurance, toripalimab (240mg), camrelizumab (200mg), tislelizumab (200mg) or others; Intravenous infusion, every 3 weeks . Nimotuzumab:: In the first 6 cycles, 200 mg, intravenous infusion, every 1 week, and 400 mg is administered for the first time. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks Maintenance phase: Anti-PD1 monoclonal antibody: anti-PD-1 monoclonal antibody drugs, Intravenous infusion, every 3 weeks. Nimotuzumab treatment: 400 mg, intravenous infusion, every 3 weeks. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks; The duration of treatment is 1 year or until intolerable toxic reactions occur, or disease progresses, or the patient withdraws consent, or the investigator determines that the patient needs to withdraw from treatment.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Nanchang, Jiangxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06259721), the sponsor (Jiangxi Provincial Cancer Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06259721 clinical trial studying?

The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06259721?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06259721?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06259721. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06259721. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.