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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal Carcinoma

A Prospective, Single-Arm Phase II Clinical Trial on the Efficacy and Safety of Sintilimab Combined With Anlotinib and Taxane-Based Chemotherapy in Previously Immunotherapy-Treated Recurrent/Metastatic Nasopharyngeal Carcinoma

Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal Carcinoma (NCT07581821) is a Phase 2 interventional studying Recurrent or Metastatic Nasopharyngeal Carcinoma, sponsored by Ming-Yuan Chen. 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

This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of sintilimab combined with anlotinib and taxane-based chemotherapy 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Recurrent or Metastatic 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 33 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. Sign a written willing to sign a consent form before implementing any trial-related procedures. 2. Age is 18 or older and 65 or younger. 3. Nasopharyngeal nonkeratinizing carcinoma (differentiated or undifferentiated, i.e. WHO type II or III) with histological or cytological evidence. 4. Recurrent or metastatic nasopharyngeal carcinoma that has failed previous treatment with first-line platinum-containing standard regimens and/or second-line standard regimens. 5. At least one measurable lesion according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1) is considered measurable if a lesion in a previously irradiated field is confirmed to have progressed; 6. Participants with asymptomatic brain metastases or stable symptoms after local treatment may be enrolled, provided they meet the following criteria: 1) Measurable lesions outside the central nervous system; 2) No central nervous system symptoms or no symptom exacerbation within at least two weeks; 3) No need for glucocorticoid therapy, discontinued glucocorticoid treatment within seven days prior to initial administration, or stabilized glucocorticoid dosage within seven days prior to initial administration reduced to below 10 mg/day prednisone (or equivalent dose) 7. Allow the subject to receive palliative radiotherapy (including cranial radiotherapy for symptomatic brain metastases), provided that the radiotherapy is completed at least 1 week prior to enrollment and that the toxicity associated with radiotherapy is restored to less than or equal to grade 1 (CTCAE 5.0, except for hair loss) 8. ECOG score 0-1. 9. Life expectancy\> 3 months. 10. If there is a risk of pregnancy, all subjects (male or female) should use contraception with an annual failure rate of less than 1% throughout the treatment period and for 120 days after the last study drug administration (or 180 days after the last study drug administration). Who Should NOT Join This Trial: ...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. Sign a written informed consent before implementing any trial-related procedures. 2. Age is 18 or older and 65 or younger. 3. Nasopharyngeal nonkeratinizing carcinoma (differentiated or undifferentiated, i.e. WHO type II or III) with histological or cytological evidence. 4. Recurrent or metastatic nasopharyngeal carcinoma that has failed previous treatment with first-line platinum-containing standard regimens and/or second-line standard regimens. 5. At least one measurable lesion according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1) is considered measurable if a lesion in a previously irradiated field is confirmed to have progressed; 6. Participants with asymptomatic brain metastases or stable symptoms after local treatment may be enrolled, provided they meet the following criteria: 1) Measurable lesions outside the central nervous system; 2) No central nervous system symptoms or no symptom exacerbation within at least two weeks; 3) No need for glucocorticoid therapy, discontinued glucocorticoid treatment within seven days prior to initial administration, or stabilized glucocorticoid dosage within seven days prior to initial administration reduced to below 10 mg/day prednisone (or equivalent dose) 7. Allow the subject to receive palliative radiotherapy (including cranial radiotherapy for symptomatic brain metastases), provided that the radiotherapy is completed at least 1 week prior to enrollment and that the toxicity associated with radiotherapy is restored to less than or equal to grade 1 (CTCAE 5.0, except for hair loss) 8. ECOG score 0-1. 9. Life expectancy\> 3 months. 10. If there is a risk of pregnancy, all subjects (male or female) should use contraception with an annual failure rate of less than 1% throughout the treatment period and for 120 days after the last study drug administration (or 180 days after the last study drug administration). Exclusion Criteria: 1. Diagnosis of a malignancy other than nasopharyngeal carcinoma within 5 years prior to the first dose (excluding cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or cured carcinoma in situ that has been resected); 2. Participants are currently enrolled in an interventional clinical study treatment or have received another investigational drug or used an investigational device within 4 weeks prior to the first dose 3. Within 2 weeks before the first administration, patients received systemic treatment with traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) for anti-tumor indications 4. Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) that occurred within 2 years prior to the first treatment. Replacement therapy (e.g., thyroid hormone, insulin, or physiologically administered glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy 5. Study participants were receiving systemic glucocorticoid therapy (not including nasal, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first study administration; 6. The presence of clinically uncontrolled pleural/abdominal effusion (no drainage is required or the subject does not show significant increase in fluid over 3 days of discontinuation of drainage is eligible for enrollment) 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Patients who are known to be allergic to the active ingredient or excipient of the study drug, sintilimab and anlotinib hydrochloride; 9. Patients with multiple factors affecting oral medications (e.g., dysphagia, postgastrectomy, chronic diarrhea, intestinal obstruction, etc.); 10. Cough, severe liver and kidney dysfunction; 11. Not fully recovered from toxicity and/or complications caused by any intervention prior to starting treatment (i.e., ≤1 grade or baseline, excluding fatigue or hair loss) 12. History of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 13. Untreated active hepatitis B (defined as HBsAg-positive with HBV DNA copy count exceeding the upper limit of normal values in the laboratory department of the research center); Note: Eligible participants also include those meeting the following criteria: 1) HBV viral loa 14. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the detection limit); 15. Vaccinated with a live vaccine within 30 days prior to the first dose (Day 1 of Week 1); Note: Influenza vaccine injections for seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal administration of live attenuated influenza vaccine is not permitted. 16. Pregnant or lactating women; 17. Participants with any severe or uncontrolled systemic diseases, such as: 1) significant and symptomatically severe abnormalities in rhythm, conduction, or morphology observed on resting electrocardiogram (e.g., complete left bundle branch block, second-degree or higher cardiac block, ventricular arrhythmias, or atrial fibrillation); 2) unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Class II or higher; 3) myocardial infarction within six months prior to enrollment; 4) suboptimal blood pressure control (systolic\>140 mmHg, diastolic\>90 mmHg); 5) history of non-infectious pneumonia requiring glucocorticoid therapy within one year prior to first administration, or current clinical active interstitial lung disease; 6) active pulmonary tuberculosis; 7) active or uncontrolled infections requiring systemic treatment; 8) active diverticulitis, peritoneal abscess, or gastrointestinal obstruction; 9) liver disorders including cirrhosis, decompensated cirrhosis, acute/chronic active hepatitis; 10) poorly controlled diabetes (fasting blood glucose\>10mmol/L); 11) urine protein ≥++ detected in urinalysis with confirmed 24-hour protein\>1.0 g; participants with psychiatric disorders and poor treatment compliance 18. History or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial and prevent the subject from participating in the study, or other conditions that the investigator deems unsuitable for enrollment, or other potential risks that the investigator deems unsuitable for participation in this study.

Treatments Being Tested

DRUG

Sintilimab + Anlotinib + taxane-based chemotherapy

Drug: Sintilimab 200mg, D1, Q3W, iv drip, Drug: Anlotinib 12mg, D1-14, Q3W, PO Drug: Taxane chemotherapy Docetaxel, 75mg/m², D1, Q3W, iv drip, maximum 6 cycles; or paclitaxel, 175mg/m², D1, Q3W, iv drip, maximum 6 cycles; or nab-paclitaxel, 260mg/m², D1, Q3W, iv drip, maximum 6 cycles. Select one chemotherapeutic drug not previously used.

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.

Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai, Guangdong, China, 519000
Zhuhai, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07581821), the sponsor (Ming-Yuan Chen), 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 NCT07581821 clinical trial studying?

This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of sintilimab combined with anlotinib and taxane-based chemotherapy 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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07581821?

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 NCT07581821?

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 NCT07581821. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07581821. 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 2026-06-07 · Data from ClinicalTrials.gov.