BridgeMD
New treatment option for Head and Neck Tumors
Official title Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors
ClinicalTrials.gov ID: NCT05758389
What this study is testing
What is Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU?
Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU is an investigational medicine, being studied as a potential treatment for head and neck tumors.
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
- The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are: 1.
- 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
- Age 18-75 years old;
- Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.;
- Have at least one radiographically measurable lesion (RECIST 1.1 criteria);
- The clinical stage is III-IVb (P16-) or II-III (P16+);
- There are tumor samples that can detect gene expression;
You likely can't join if
- Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait;
- Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years...
- There is distant metastasis;
- Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis...
- Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or...
- Severe infection (CTC AE\>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring...
See the full eligibility criteria
- Age 18-75 years old;
- Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.;
- Have at least one radiographically measurable lesion (RECIST 1.1 criteria);
- The clinical stage is III-IVb (P16-) or II-III (P16+);
- There are tumor samples that can detect gene expression;
- ECOG score 0-1 points;
- Have not received radiotherapy and chemotherapy or other anti-tumor drugs before;
- The following hematological indicators need to be met: (1) Neutrophil count≥ 1.5×109/L; (2) Hemoglobin≥ 10g/dL; (3) Platelet count ≥ 100×109/L
- The following biochemical indicators need to be met: (1) Total bilirubin ≤1.5× upper limit of normal value (ULN); (2) AST and ALT \< 1.5 ×ULN; (3) Creatinine clearance ≥ 60ml/min; (4) Alkaline phosphatase ≤ 5 times ULN...
- people of childbearing age need to take appropriate protective measures (contraceptive measures) before enrollment and in trials administration or other methods of birth control);
- Have signed informed consent;
- Ability to follow study protocols and follow-up procedures.
- Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait;
- Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma...
- There is distant metastasis;
- Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these...
- Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow...
- Severe infection (CTC AE\>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; baseline chest imaging...
- The subject has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA grade II or echocardiography showing left...
- Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ml, or patients with active hepatitis C virus (HCV) should be excluded; inactive hepatitis B surface Antigen carriers...
- Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones) and non-infectious pneumonia;
- Active tuberculosis infection was found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active...
- Patients who have received any of the following treatments (1) people who need to be given corticosteroids (\> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks...
- Pregnant and lactating women. Women of childbearing age must take a pregnancy test within 7 days before enrollment Negative;
- Substance abuse, clinical or psychological or social factors that hinder informed consent or research conduct influences;
- Those who may be allergic to the study drug;
- Those who cannot perform radiotherapy and chemotherapy due to social or geographical factors;
- Significant weight loss within 6 weeks before enrollment (weight loss ≥ 10%);
- Any uncertain factors affecting the safety or compliance of the people;
- Contraindications to hormone use.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 Nanjing, Jiangsu, 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.