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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma

GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma

GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma (NCT06455410) is a Phase 2 interventional studying Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. 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 neoadjuvant GP chemotherapy plus adebrelimab versus neoadjuvant GP chemotherapy in treating high-risk locoregionally advanced nasopharyngeal carcinoma patients.

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.

Target enrollment of 216 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Nasopharyngeal Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients must be informed of the investigational nature of this study and give written willing to sign a consent form. 2. Age ≥ 18 years and ≤65 years, men or non-pregnant women. 3. Patients with diagnosed by tissue sample (biopsy-confirmed) Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III). 4. Tumor staged as T4N0-1M0 or T1-4N2-3M0 (AJCC 8th). 5. No previous anti-tumor treatment. 6. Eastern Cooperative Oncology Group (ECOG) score 0 or 1. 7. Adequate marrow function: White blood cell count (WBC)≥4.0×109 /L, blood count (hemoglobin) at least 90g/L, Platelet count ≥100×109/L. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL) ≤2×upper limit of normal (ULN). 9. Adequate renal function: creatinine clearance rate ≥ 60 ml/min or Creatinine ≤ 1.5× upper limit of normal value. Who Should NOT Join This Trial: 1. Patients with recurrent or metastatic nasopharyngeal carcinoma. 2. diagnosed by tissue sample (biopsy-confirmed) with keratinizing squamous cell carcinoma of the nasopharynx. 3. Prior therapy with radiation or systemic chemotherapy. 4. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures. 5. Seropositivity for human weakened immune system virus (HIV). 6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix). 7. Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti- PD-L1, anti-CTLA-4 antibodies. 8. Patients with weakened immune system disease or a history of organ transplantation. 9. Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks. 10. Patients with severe dysfunction of heart, liver, lung, kidney or marrow. 11. Patients with severe, uncontrolled disease or infections. 12. Received other research drugs or in other clinical trials at the same time. ...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. Patients must be informed of the investigational nature of this study and give written informed consent. 2. Age ≥ 18 years and ≤65 years, men or non-pregnant women. 3. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III). 4. Tumor staged as T4N0-1M0 or T1-4N2-3M0 (AJCC 8th). 5. No previous anti-tumor treatment. 6. Eastern Cooperative Oncology Group (ECOG) score 0 or 1. 7. Adequate marrow function: White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL) ≤2×upper limit of normal (ULN). 9. Adequate renal function: creatinine clearance rate ≥ 60 ml/min or Creatinine ≤ 1.5× upper limit of normal value. Exclusion Criteria: 1. Patients with recurrent or metastatic nasopharyngeal carcinoma. 2. Histologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx. 3. Prior therapy with radiation or systemic chemotherapy. 4. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures. 5. Seropositivity for human immunodeficiency virus (HIV). 6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix). 7. Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti- PD-L1, anti-CTLA-4 antibodies. 8. Patients with immunodeficiency disease or a history of organ transplantation. 9. Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks. 10. Patients with severe dysfunction of heart, liver, lung, kidney or marrow. 11. Patients with severe, uncontrolled disease or infections. 12. Received other research drugs or in other clinical trials at the same time. 13. Refuse or fail to sign the informed consent . 14. Patients with other treatment contraindications. 15. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct. 16. Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV deoxyribonucleic acid (HBV DNA) ≥1000cps/ml or 200 IU/ml. 17. Patients with positive HCV antibody test will only be enrolled in this study if the PCR test for HCV RNA is negative.

Treatments Being Tested

DRUG

GP

gemcitabine + cisplatin

DRUG

Adebrelimab

a PD-L1 inhibitor

DRUG

concurrent chemoradiotherapy (CCRT)

concurrent chemoradiotherapy (CCRT)

Locations (12)

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.

Foshan First People's Hospital
Foshan, Guangdong, China
Affiliated cancer hospital and institute of guangzhou medical university
Guangzhou, China
Sun Yat-Sen Memorial Hospital
Guangzhou, China
The affiliated panyu central hospital of guangzhou medical university
Guangzhou, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, China
Liuzhou Workers Hospital
Liuzhou, China
Guangxi Medical University Affiliated Cancer Hospital
Nanning, China
Cancer hospital of Shantou university medical college
Shantou, China
Cancer hospital Chinese academy of medical sciences, Shenzhen center
Shenzhen, China
The second people's hospital of Shenzhen
Shenzhen, China
The university of Hongkong - Shenzhen hospital
Shenzhen, China
Guangdong Medical School First Affiliated Hospital
Zhangjiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06455410), the sponsor (Sun Yat-sen University), 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 NCT06455410 clinical trial studying?

The purpose of this study is to explore the efficacy and safety of neoadjuvant GP chemotherapy plus adebrelimab versus neoadjuvant GP chemotherapy in treating high-risk locoregionally advanced nasopharyngeal carcinoma patients. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06455410?

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 NCT06455410?

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 NCT06455410. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06455410. 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.