New drug combo aims to stop advanced nose cancer from coming back
NCT ID NCT07540390
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding an immunotherapy drug (PD-1 antibody) and a targeted therapy (anlotinib) to standard chemotherapy and radiation can help prevent cancer from returning in people with high-risk, advanced nasopharyngeal carcinoma. About 442 adults aged 18-65 with stage III disease will be enrolled. The study compares the new combination against the current standard treatment to see if it improves 3-year survival without cancer progression.
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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 442 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2032
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: * Voluntary participation and signed informed consent. * Age 18-65 years, male or non-pregnant female. * Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III). * Previously untreated patients with no history of other malignancies; initial treatment for nasopharyngeal carcinoma. * Stage III: TanyN3M0 / T4N0-2M0 (9th AJCC/UICC staging system). * ECOG performance status 0-1, with no severe dysfunction of vital organs (heart, lung, liver, kidney, etc.). * Hemoglobin (HGB) ≥90 g/L, white blood cell count (WBC) ≥4.0×10\^9 /L, platelet count (PLT) ≥100×10\^9/L. * Liver function: ALT and AST \<2.5× upper limit of normal (ULN); total bilirubin \<2.0×ULN. * Renal function: serum creatinine \<1.5×ULN. Exclusion Criteria: * Patients with recurrent or distant metastatic nasopharyngeal carcinoma. * Pathologically confirmed keratinizing squamous cell carcinoma (WHO type I). * Receipt of systemic or topical glucocorticoid therapy within 4 weeks prior to enrollment. * Participation in another clinical trial of an investigational drug within 3 months prior to treatment. * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Patients with idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans), radiation pneumonitis that is clinically symptomatic or requires steroid therapy, active pneumonitis, or other moderate-to-severe pulmonary diseases that significantly affect lung function. * Comorbidities requiring long-term immunosuppressive medication or systemic/topical corticosteroids at immunosuppressive doses. * Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulatory or checkpoint pathways) with documented disease progression at the time of study entry. * Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients requiring bronchodilators for medical management of asthma are excluded. * HIV-positive; HBsAg-positive with detectable HBV DNA copy number (quantitative detection ≥1000 cps/mL); positive hepatitis C antibody (HCV Ab) with detectable HCV RNA. * Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine) within 4 weeks prior to enrollment. * Positive pregnancy test in women of childbearing potential, or lactating women. * Inability to comply with scheduled follow-up due to psychological, social, family, or geographical reasons.
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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
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- Can an experimental drug shrink advanced solid tumors?
- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
- Smart T-Cell engager aims to outsmart tumors in first human test