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Study on Electrochemotherapy with Bleomycin for Patients with Recurrent Oral and Oropharyngeal 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 is focused on studying a treatment for squamous cell carcinoma of the oral cavity and oropharynx, which are areas in the mouth and throat. The study is investigating the effectiveness of a treatment called electrochemotherapy, which combines the use of electrical impulses with a drug called bleomycin. This treatment will be compared to a combination of other medications, including cetuximab, platinum-based therapy (such as carboplatin or cisplatin), and 5-fluorouracil.

The purpose of the study is to determine if electrochemotherapy with bleomycin is more effective in treating the cancer compared to the other combination of drugs. Participants in the study will receive either the electrochemotherapy treatment or the combination of cetuximab, platinum-based therapy, and 5-fluorouracil. The study will monitor the response of the cancer to these treatments, as well as overall survival, the time the disease remains under control, and the quality of life of the participants.

Throughout the study, participants will receive their assigned treatment and be regularly assessed to track the progress of their cancer and any side effects they may experience. The study aims to provide valuable information on the best treatment options for patients with recurrent squamous cell carcinoma of the oral cavity and oropharynx.

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

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and current health status. The assessment ensures that you meet the criteria for participation, such as having a confirmed diagnosis of squamous cell carcinoma in the oral cavity or oropharynx.

  3. Step 3

    Treatment allocation

    You will be randomly assigned to one of two treatment groups. One group will receive electrochemotherapy with bleomycin, and the other group will receive a combination of cetuximab, platinum-based therapy (such as carboplatin or cisplatin), and 5-fluorouracil.

  4. Step 4

    Treatment administration

    If you are in the electrochemotherapy group, you will receive bleomycin through an intravenous injection. The treatment involves applying electrical impulses to the tumor area to enhance the drug's effectiveness.

    If you are in the other group, you will receive cetuximab, platinum-based therapy, and 5-fluorouracil through intravenous injections. The specific dosage and frequency will be determined by the medical team based on your individual needs.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes physical examinations, imaging tests, and blood tests. The medical team will evaluate the effectiveness of the treatment and monitor for any side effects.

    You will be asked to complete questionnaires to assess your quality of life, focusing on aspects such as pain and bleeding.

  6. Step 6

    End of trial

    The trial is expected to conclude by December 31, 2025. At the end of the trial, a final assessment will be conducted to evaluate the overall outcomes and your health status. You will receive information about the results and any further steps if necessary.

Who can join the trial?

8 criteria

  • Must be over 18 years old.
  • Must have a progressive disease in the oral cavity and oropharynx. This means the disease is getting worse or coming back after treatment.
  • Must have a histological confirmation of head and neck squamous cell carcinoma. This means a tissue sample has been tested and confirmed to be this type of cancer.
  • Must have measurable lesions that can be treated with electrical impulses. Lesions are areas of abnormal tissue.
  • Must have a performance status of Karnofsky score 70 or WHO score 2. This is a measure of how well you can carry out daily activities.
  • Must have a life expectancy of more than 3 months.
  • Must be able to understand the treatment and sign an informed consent. This means you understand the treatment and agree to participate.
  • Must have refused other treatments.

Who cannot join the trial?

5 criteria

  • Patients with any other type of cancer besides carcinoma of the oral cavity and oropharynx cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
  • Patients who are not eligible for the specific treatment being tested in the study cannot participate.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
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Investigated drugs

  • Electrochemotherapy

    is a treatment that combines a special type of electrical pulse with a cancer-fighting drug. In this trial, it is used as a first-line treatment for patients with recurrent squamous cell carcinoma in the mouth and throat areas. The electrical pulses help the drug enter the cancer cells more effectively, which can lead to better treatment results.

  • Bleomycin

    is a medication used in this trial as part of the electrochemotherapy treatment. It is a type of chemotherapy drug that works by damaging the DNA inside cancer cells, which can stop them from growing and multiplying. When used with electrochemotherapy, it is expected to be more effective in treating the cancer.

  • Cetuximab

    is a medication that targets specific proteins on the surface of cancer cells. It is used in this trial in combination with other drugs to treat squamous cell carcinoma. By blocking these proteins, cetuximab can help slow down or stop the growth of cancer cells.

  • Platinum-based therapy

    refers to a group of chemotherapy drugs that contain the metal platinum. These drugs work by damaging the DNA of cancer cells, which can prevent them from growing and dividing. In this trial, platinum-based therapy is used alongside other treatments to help fight the cancer.

  • 5-Fluorouracil

    is a chemotherapy drug used in this trial to treat squamous cell carcinoma. It works by interfering with the cancer cells' ability to make DNA and RNA, which are essential for their growth and division. This can help slow down or stop the spread of cancer.

What is already known about the treatment

Bleomycin – Bleomycin is administered through an injection, often directly into the bloodstream or the tumor area, as part of a treatment called electrochemotherapy. It is currently being studied in clinical trials for its effectiveness in treating recurrent squamous cell carcinoma of the oral cavity and oropharynx. The main therapeutic use of Bleomycin in this context is to help shrink tumors and improve patient outcomes. At the molecular level, Bleomycin works by causing breaks in DNA strands, which leads to cancer cell death. It is classified as an antineoplastic antibiotic, which means it is a type of cancer-fighting drug derived from natural sources.

Investigated diseases

Carcinoma of the Oral Cavity and Oropharynx – This disease involves the abnormal growth of cells in the oral cavity, which includes the lips, tongue, gums, and other areas inside the mouth, as well as the oropharynx, which is the part of the throat at the back of the mouth. It typically begins as a small lesion or sore that does not heal and may bleed easily. As the carcinoma progresses, it can invade deeper tissues and spread to nearby structures, such as the jawbone or lymph nodes in the neck. The disease may cause symptoms like difficulty swallowing, changes in speech, or persistent pain. Over time, the cancerous cells can metastasize to other parts of the body, complicating the condition further. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520735-16-00Estimated enrolment96 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

sourced from the EU Clinical Trials Register and site verification

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