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Study of toripalimab, cisplatin and gemcitabine combination as first treatment for patients with recurrent or metastatic nasopharyngeal cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates a treatment for recurrent metastatic nasopharyngeal carcinoma, a type of cancer that starts in the nasopharynx (the upper part of the throat behind the nose) and has spread to other parts of the body or has come back after previous treatment. The study evaluates a combination therapy using toripalimab (a type of immunotherapy drug) together with gemcitabine and cisplatin chemotherapy as a first treatment for patients whose cancer cannot be treated with local therapies.

The main purpose of this study is to understand how safe this combination treatment is by monitoring serious side effects that may occur during therapy. The treatment involves receiving the medications through intravenous infusion. The study will track how patients respond to the treatment and measure both the time until the cancer might progress and overall survival.

The study will include adult patients who have measurable cancer that can be seen on imaging scans and who have not received previous systemic therapy for their recurrent or metastatic disease. Patients must have confirmation of their Epstein-Barr virus status and be in relatively good physical condition to participate.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive a combination of three medications through intravenous infusion (delivered directly into your vein):

    - Toripalimab (LOQTORZI)

    - Gemcitabine

    - Cisplatin

    These medications will be administered to treat recurrent or metastatic nasopharyngeal cancer (cancer that has returned or spread to other parts of the body)

  2. Step 2

    Monitoring period

    Your health will be closely monitored for any side effects or reactions to the treatment

    Regular assessments will include:

    - Physical examinations

    - Blood tests

    - Imaging scans to check how the cancer responds to treatment

  3. Step 3

    Treatment continuation

    Treatment will continue as long as:

    - The cancer does not show signs of progression

    - Side effects remain manageable

    - Your general health status allows for continued treatment

  4. Step 4

    Follow-up period

    After completing treatment, you will have regular follow-up visits to monitor:

    - Your overall health status

    - Any lasting side effects

    - How well the cancer has responded to treatment

    The study is planned to continue until April 2033

Who can join the trial?

11 criteria

  • Must be able to provide written informed consent before starting any study procedures
  • Must be willing and able to follow the study schedule, including:
    • Attending all planned visits
    • Following treatment schedule
    • Completing required laboratory tests
    • Must be 18 years or older
    • Must have confirmed nasopharyngeal cancer (cancer that starts in the upper part of the throat behind the nose) that has:
      • Come back after previous treatment, or
      • Spread to other parts of the body
      • Must have an ECOG performance status of 2 or less (ability to carry out daily activities, where 0 means fully active and 2 means able to do light activities but unable to work)
      • Must not have received any previous systemic treatment (medication that travels through the bloodstream) for recurring or spreading nasopharyngeal cancer
      • Must have tumors that can be measured by CT scan (detailed X-ray) or MRI (magnetic resonance imaging)
      • Must have documentation of Epstein-Barr virus (EBV) status (a common virus that can be associated with this type of cancer) from initial diagnosis and current blood levels

Who cannot join the trial?

15 criteria

  • Prior treatment with any anti-PD-1 or anti-PD-L1 therapy (types of immunotherapy that help your immune system fight cancer)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Active autoimmune disease requiring systemic treatment (conditions where your immune system attacks your own body)
  • History of organ transplantation
  • Uncontrolled heart conditions or heart failure
  • Active hepatitis B or C infection (liver infections)
  • Known HIV infection
  • Pregnant or breastfeeding women
  • Major surgery within 4 weeks before starting the study treatment
  • Current participation in other clinical trials
  • Severe allergic reactions to previous cancer treatments
  • Active tuberculosis infection
  • Serious uncontrolled medical conditions that could interfere with study treatment
  • Use of systemic steroids (except for specific medical conditions approved by study doctor)
  • Mental conditions that prevent understanding of study requirements
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Investigated drugs

Toripalimab is a type of immunotherapy medication that helps the body's immune system fight cancer cells. It belongs to a class of drugs called PD-1 inhibitors, which work by blocking certain proteins that prevent the immune system from attacking cancer cells. This medication is being studied in combination with chemotherapy for treating nasopharyngeal cancer that has spread or come back. Standard Chemotherapy medications are used in combination with toripalimab in this trial. Chemotherapy drugs work by killing cancer cells or stopping them from growing and dividing. The combination of chemotherapy with immunotherapy may help improve the treatment's effectiveness for patients with nasopharyngeal cancer.

What is already known about the treatment

Toripalimab - A monoclonal antibody administered through intravenous infusion, which belongs to the class of immune checkpoint inhibitors used in cancer immunotherapy. This medication works by blocking PD-1 (programmed cell death protein 1) receptors on T-cells, thereby enhancing the immune system's ability to detect and destroy cancer cells. It is currently being investigated in clinical trials for the treatment of recurrent or metastatic nasopharyngeal carcinoma in combination with chemotherapy, showing promising results in non-endemic populations. The medication represents a targeted approach to cancer treatment by modulating the immune system's response against cancer cells.

Investigated diseases

Nasopharyngeal Carcinoma – A cancer that develops in the nasopharynx, which is the upper part of the throat behind the nose. This cancer begins in the epithelial cells that line the nasopharynx. It can spread to nearby lymph nodes in the neck, and in advanced cases, it can metastasize to other parts of the body. The cancer may be associated with Epstein-Barr virus (EBV) infection in some cases. When the disease becomes recurrent and metastatic, it means the cancer has returned after initial treatment and has spread to other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522472-85-00Estimated enrolment49 patientsSponsorHumanitas Mirasole S.p.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).