New triple therapy aims to control advanced nose cancer
NCT ID NCT06802835
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs—an EGFR antibody, a PD-1 inhibitor, and chemotherapy—in people whose nasopharyngeal cancer has returned or spread. The goal is to see if this mix can slow or stop the cancer from growing. About 148 adults aged 18-75 who have not had prior treatment for their recurrent or metastatic disease will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2029
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 75 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: * Patients with nasopharyngeal carcinoma who have recurred/metastasized after initial treatment or radical treatment; * Age 18-75, male or female; * Pathological diagnosis of nasopharyngeal carcinoma; * ECOG score 0-1; * Have not previously received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biotherapy for recurrence/metastasis; * No contraindications of chemotherapy, immunotherapy and targeted therapy; * At least 1 measurable lesion that meets RECIST 1.1 criteria; * Blood routine examination standards should meet: WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L, HGB≥90g/L (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct); * Biochemical tests should meet the following criteria: TBIL≤2.0×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance ≥60ml/min (Cockcroft-Gault formula); * Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the intended range of anticoagulant drug use; * The myocardial enzyme spectra were in the normal range; * Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days of enrollment with a negative result and be willing to use an effective method of contraception during the trial and for 3 months after the last anti-PD-1 antibody administration. For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial and within 3 months after the last anti-PD-1 antibody administration; * The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up; Exclusion Criteria: * Patients with recurrence who can be treated with local resection or radiotherapy; * Known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies; * Patients have symptoms of central nervous system metastasis such as brain edema and need hormonal intervention; * Had an active infection or unexplained fever \>38.5℃ during screening or prior to the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled); * Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[may be included after normal hormone replacement therapy\]); Patients with vitiligo or complete remission of asthma in childhood without any intervention as adults could be included, but patients with asthma requiring medical intervention with bronchodilators could not be included; * Have congenital or acquired immunodeficiency (such as HIV), active hepatitis B (HBV-DNA≥103 copy number /ml), or hepatitis C (hepatitis C antibody positive and HCR-RNA above the lower detection limit of analytical methods); * Previous or co-existing uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer; * Uncontrolled cardiovascular disease: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); Patients with grade III-IV cardiac insufficiency according to NYHA standards, or left ventricular ejection fraction (LVEF) \<50% indicated by cardiac color ultrasound; Myocardial infarction within 1 year; * If the subject has undergone major surgery, the toxic effects and/or complications of the surgical intervention must be fully recovered before treatment is initiated; * Within 4 weeks prior to the first use of the investigational drug (participants in the follow-up period are counted as the last use of the investigational drug or device) or are currently participating in another clinical study; * Live vaccine received within 4 weeks prior to the first administration of the investigational drug is allowed to receive inactivated virus vaccine for seasonal influenza by injection, but not live attenuated influenza vaccine for nasal administration; * Pregnant or lactating women; * In the investigator's judgment, the subjects had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the safety of the subjects or the circumstances of the trial data collection.
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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, China
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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
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