New combo therapy aims to outsmart nasopharyngeal cancer
NCT ID NCT07154069
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding immunotherapy to standard treatment can improve outcomes for people with advanced nasopharyngeal cancer. About 802 participants will be split into low-risk and high-risk groups to see if personalized treatment can reduce side effects and prevent the cancer from coming back. The study compares different combinations of chemotherapy, radiation, and immunotherapy drugs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 802 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 18-65 years; * Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria); * Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system; * ECOG performance status: 0-1; * Adequate bone marrow function: white blood cell count \> 4 × 10⁹/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10⁹/L; * Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min; * Normal thyroid function, amylase, lipase, pituitary function; * Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy; * Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures; * Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment. Exclusion Criteria: * T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition; * Disease progression after induction therapy; * Hepatitis B surface antigen (HBsAg) positive with HBV DNA \>1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive; * Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS); * Active tuberculosis; * Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); * History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year; * Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible; * Uncontrolled cardiac disease; * Pregnant or lactating women; * History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma; * Known allergy to macromolecular protein preparations or any component of toripalimab; * Active infection requiring systemic treatment within one week prior to enrollment; * Administration of a live vaccine within 30 days before the first dose of toripalimab; * History of organ transplantation; * Contraindications to MRI examination, which would prevent the completion of required imaging; * Any other condition deemed by the investigators to potentially compromise patient safety or compliance.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug duo aims to keep advanced nasopharyngeal cancer in check
- New surveillance strategy aims to catch residual cancer early in High-Risk nasopharyngeal carcinoma
- New combo strategy aims to catch and remove leftover cancer after radiation