Can a Platinum-Free regimen beat nasopharyngeal carcinoma?

NCT ID NCT07794488

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This phase II trial tests a new treatment approach for people with locally advanced nasopharyngeal carcinoma, a type of head and neck cancer. The regimen avoids platinum-based chemotherapy, using a combination of gemcitabine, camrelizumab, endostar, and low-dose radiotherapy before the main treatment. After this neoadjuvant phase, the treatment is tailored to each patient's response: those with a complete response receive radiotherapy alone, those with a partial response get radiotherapy plus endostar, and those with stable or progressive disease receive radiotherapy plus cisplatin. The study aims to see if this strategy improves recurrence-free survival compared to standard care.

What this could mean

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

Active substance
A combination of gemcitabine, camrelizumab, endostar, and low-dose radiotherapy, followed by risk-adapted treatment
What this could lead to
If successful, this approach could offer a less toxic, effective treatment for nasopharyngeal carcinoma, potentially reducing recurrence and improving survival without platinum-based chemotherapy.
What could go wrong
This is a phase II trial, so results are preliminary. The regimen may not improve outcomes, and there are risks of side effects from the drugs and radiation, including immune-related reactions from camrelizumab.

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 145 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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: 1. Age at diagnosis between 18 and 70 years. 2. Histopathologically confirmed newly diagnosed nasopharyngeal carcinoma, classified as non-keratinizing carcinoma or keratinizing squamous cell carcinoma according to the World Health Organization (WHO) classification. 3. Diagnosed with stage II/III nasopharyngeal carcinoma (excluding T3N0) based on the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system, 9th edition. All subjects must undergo the following examinations prior to the initiation of first-line treatment to confirm clinical staging: complete medical history, physical examination, routine blood tests and biochemical assays, plasma Epstein-Barr virus (EBV) DNA titer and serological tests, nasopharyngoscopy, head and neck magnetic resonance imaging (MRI), and ¹⁸F-fluorodeoxyglucose positron emission tomography (¹⁸F-FDG PET). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Normal bone marrow function: white blood cell count \> 4×109/L, hemoglobin \> 90g/L, platelet count \> 100×109/L; 6. Normal values of thyroid function, amylase and lipase examination, pituitary function, inflammation and infection indicators, myocardial enzymes, and ECG results. For patients older than 50 years with a smoking history, normal lung function are required. Patients with abnormal ECG and/or a history of vascular disease (but not meeting the exclusion criteria listed in the exclusion criteria 7) need further testing and require normal results of myocardial function and color Doppler ultrasound. 7. Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine transaminase and aspartate transaminase ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance rate ≥ 60 ml/min; 8. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule; 9. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment. Exclusion Criteria: 1. Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA \> 1×10E3 copies/ml; anti-hepatitis C virus positive; 2. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS); 3. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment; history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved; Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia); 4. Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy; 5. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible; 6. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2); 2) unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention; 7. Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility); 8. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer; 9. Allergy to macromolecular protein preparations, or any component of camrelizumab; 10. Active infection requiring systemic treatment; 11. Receiving live vaccine within 30 days of the initial camrelizumab; 12. History of organ transplantation; 13. History of psychotropic disease, alcoholism or drug abuse; other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors. \-

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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

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  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

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Contacts and locations

Locations

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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