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New treatment option for Oral Squamous Cell Carcinoma
Official title Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial
ClinicalTrials.gov ID: NCT05862168
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oral squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed the informed consent form
- Histopathological diagnosis of oral squamous cell carcinoma
- Age: 18-75 years old , Gender: male and female
- Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
You likely can't join if
- Known history of malignancy, unless been cured and no recurrence for 5 years
- Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
- Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
- Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment...
- Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.
- people with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis...
See the full eligibility criteria
- Signed the informed consent form
- Histopathological diagnosis of oral squamous cell carcinoma
- Age: 18-75 years old , Gender: male and female
- Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
- No previous systematic therapy for OSCC (including chemotherapy, EGFR inhibitors, VEGFR inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, anti-ctLA-4 antibodies, etc.);
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Adequte organ function based on laboratory test values obtained during the screening period：1）Blood routine: white blood cells (WBCs) \>3.0× 109/L, ANC \>1.5× 109/L, platelets \>75× 109/L, hemoglobin \>9 g/L, 2）Liver...
- contraception
- Known history of malignancy, unless been cured and no recurrence for 5 years
- Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
- Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
- Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator.
- Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.
- people with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection.
- Serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis...
- Known human immunodeficiency virus (HIV) infection
- people with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies/ml [200 IU/ml] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required...
- History of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis.
- Known allergic reaction to any ingredients or excipients of the therapy
- Participation in other clinical trials within 30 days before enrollment
- Pregnant or lactating women
- Known alle Other situations that the investigator considers unsuitable with respect to participating in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.