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Immunotherapy cocktail takes on tough throat cancer

NCT ID NCT07392320

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding an immunotherapy drug (penpulimab) to standard chemotherapy and radiation, followed by maintenance immunotherapy, works better than the usual maintenance drug capecitabine for people with high-risk nasopharyngeal cancer. About 142 participants with advanced disease will be randomly assigned to one of two treatment groups. The goal is to see which approach better prevents the cancer from returning or spreading.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Penpulimab (immunotherapy drug) combined with chemotherapy (docetaxel, cisplatin) and radiation, compared to capecitabine (chemotherapy pill)
What this could lead to
If this works, it could offer a more effective treatment plan for high-risk nasopharyngeal cancer, potentially improving survival without the cancer coming back.
What could go wrong
This is a small, early-phase (Phase 2) trial, so results may not apply to everyone. Immunotherapy can cause immune-related side effects, and the added benefit over standard care is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntary participation and written informed consent must be signed. * Age between 18 and 70 years, male or non-pregnant female. * Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III). * Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml. * Efficacy after 3 cycles of induction immunochemotherapy assessed as complete response (CR) or partial response (PR) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck. * ECOG performance status score of 0 or 1. * Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010\^9/L, and Platele (PLT) ≥10010\^9/L. * Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L. * Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula). * International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening). Exclusion Criteria: * Patients with recurrent or distant metastatic nasopharyngeal carcinoma. * Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I). * Patients who have previously received radiotherapy or systemic chemotherapy. * Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception. * HIV positive. * History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ). * Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors). * Patients with immunodeficiency diseases or a history of organ transplantation. * History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. * Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks. * Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function. * Patients with severe, uncontrolled medical conditions or infections. * Concurrent use of other investigational drugs or participation in another clinical trial. * Refusal or inability to sign the informed consent form for trial participation. * Patients with other contraindications to the treatment. * Patients with personality or psychiatric disorders, or those lacking or with limited legal capacity. * Patients who are hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus DNA (HBV DNA) ≥ 1000 copies/ml. Patients who are HBsAg positive but have HBV DNA \< 1000 copies/ml are eligible if the investigator determines that their chronic hepatitis B is stable and does not pose an increased risk. * Patients with a positive HCV antibody test result, unless the polymerase chain reaction (PCR) test for HCV RNA is negative.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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