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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Central Hospital Of Bolzano	Bolzano	Italy
Ospedale San Giovanni Bosco	Turin	Italy
Aeautkx Uowcq Slpmfxxpi Lqxhag Dh Bnooufm	Bologna	Italy
Aqcbmia Ocmxcuzgfse Paud Gurufnce Xxzqf	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.06.2026

Trial locations

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.

Investigated diseases:

Squamous cell carcinoma of the oral cavity

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 ID:

2024-517565-16-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?