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Study of carboplatin, paclitaxel, and tislelizumab treatment in patients with resectable locally advanced oral cavity squamous cell carcinoma

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What is this trial about?

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

This study focuses on patients with Oral Cavity Squamous Cell Carcinoma, a type of cancer that develops in the mouth tissues. The study will test a combination of three medications: tislelizumab, carboplatin, and paclitaxel. These medications will be given through intravenous infusion (delivered directly into a vein). The purpose is to evaluate how well this combination of drugs works in treating locally advanced oral cavity cancer that can be removed by surgery.

The treatment involves receiving the three medications before surgery. Tislelizumab is a newer type of drug that helps the immune system fight cancer cells, while carboplatin and paclitaxel are established chemotherapy medications that work by stopping cancer cells from growing and dividing. The medications will be given in cycles through an intravenous line, with specific doses calculated based on each patient's body measurements.

The study will measure how well the treatment works by examining the cancer tissue removed during surgery and checking how many cancer cells remain after the treatment. Doctors will also monitor patients' health during and after treatment to understand how safe this combination of medications is and how well it prevents the cancer from returning.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your medical condition will be confirmed as oral cavity squamous cell carcinoma that can be treated with surgery

    Laboratory tests will check your organ function and blood counts

    A tissue sample (biopsy) will be taken to analyze specific markers in your cancer cells

  2. Step 2

    Treatment preparation

    Before starting treatment, you will need to provide blood samples

    If you are a woman who can become pregnant, a pregnancy test will be performed

    You will receive detailed information about required birth control methods that must be used during treatment and for 6 months after

  3. Step 3

    Medication administration

    You will receive three medications through an intravenous infusion (directly into your vein):

    - Paclitaxel (6 mg/ml solution)

    - Carboplatin (10 mg/ml solution)

    - Tislelizumab (concentrated solution)

    These medications will be given before your planned surgery

  4. Step 4

    Monitoring

    Your health will be regularly checked for any side effects

    Blood samples will be taken to monitor your response to treatment

    The effectiveness of the treatment will be measured by examining how much of the tumor remains active

  5. Step 5

    Surgery

    After the medication treatment period, surgery will be performed to remove the tumor

    The removed tissue will be examined to determine how well the treatment worked

  6. Step 6

    Follow-up period

    Your recovery will be monitored for up to 3 years

    Regular check-ups will track your health status and watch for any signs of cancer return

    You will need to continue using birth control methods for 6 months after the last treatment

Who can join the trial?

13 criteria

  • Must be at least 18 years old, male or female
  • Must have adequate organ and blood function, including: - Normal white blood cell count (neutrophils) - Adequate hemoglobin levels (a protein that carries oxygen in blood) - Normal platelet count (blood cells that help with clotting) - Normal liver function tests - Adequate kidney function
  • Must not donate blood during the study and for 90 days after the last treatment
  • Women who can become pregnant must: - Have a negative pregnancy test before starting - Not be breastfeeding - Use effective birth control during the study and for 6 months after treatment ends
  • Men who are sexually active must: - Use condom and spermicide during the study and for 6 months after treatment - Not donate sperm during this period - Consider sperm preservation before treatment if planning future children
  • Must have squamous cell carcinoma (a type of cancer) of the oral cavity confirmed by tissue examination
  • Cancer must be suitable for surgery with intent to cure
  • Must have Stage III-IV cancer that has not spread to other parts of the body
  • Must meet specific biological markers in the tumor tissue
  • Must have good physical function (ECOG 0-1, meaning able to perform daily activities)
  • Must provide tumor tissue samples through biopsy
  • Must be willing to provide blood samples
  • Must be able to understand and sign informed consent documents

Who cannot join the trial?

15 criteria

  • Previous treatment with any anti-cancer therapy for oral cavity cancer
  • History of other cancers within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Active autoimmune disease (a condition where your immune system attacks your own body) requiring systemic treatment
  • Uncontrolled or significant heart disease
  • Presence of metastases (cancer spread to other parts of the body)
  • Known active hepatitis B or hepatitis C infection
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding women
  • Known allergic reactions to study medications
  • Major surgery within 4 weeks before starting the study treatment
  • Participation in another clinical trial within 30 days before this study
  • Psychiatric conditions that could interfere with study participation
  • Uncontrolled high blood pressure
  • Serious lung disease or breathing problems
  • Inability to swallow oral medications
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Investigated drugs

  • Carboplatin

    is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell DNA, which helps stop cancer cells from growing and dividing.

  • Paclitaxel

    is a chemotherapy medication that belongs to a class of drugs called taxanes. It works by stopping cancer cells from dividing and growing, ultimately causing them to die. It is commonly used in combination with other cancer treatments.

  • Tislelizumab

    is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents the immune system from attacking cancer cells. By blocking PD-1, tislelizumab allows the immune system to better recognize and destroy cancer cells.

What is already known about the treatment

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously in hospital settings, commonly used in cancer treatment. It works by binding to DNA in cancer cells, preventing them from dividing and ultimately leading to their death. This medication belongs to the alkylating agents class of chemotherapy drugs and is often used in combination with other anticancer medications for treating various types of cancer, including head and neck cancers.

  • Paclitaxel

    An intravenously administered chemotherapy medication derived from the Pacific yew tree. It works by preventing cancer cell division by stabilizing microtubules, essential cellular structures involved in cell division. This medication belongs to the taxane family of drugs and is widely used in various cancer treatments, particularly effective in treating solid tumors including those in the head and neck region.

  • Tislelizumab

    A novel immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors. It works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively. This medication represents a newer generation of cancer treatments that harness the body's own immune system to fight cancer cells, and it has shown promising results in clinical trials for various types of cancer, including head and neck cancers.

Investigated diseases

Oral Cavity Squamous Cell Carcinoma - A type of cancer that develops in the cells lining the oral cavity, including areas such as the tongue, gums, floor of the mouth, and inner cheeks. The disease begins when squamous cells start to grow uncontrollably and form tumors in the mouth's tissues. These cancer cells can initially develop as pre-cancerous changes in the oral cavity's lining before progressing to invasive cancer. In locally advanced cases, the cancer has grown larger or spread to nearby tissues but remains in the head and neck region. The disease can affect normal oral functions such as speaking, eating, and swallowing.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517565-16-00Estimated enrolment28 patientsSponsorFondazione GONO Plus

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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).