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Tests treatment safety and results for Head and Neck Squamous Cell Carcinoma
Official title Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC
ClinicalTrials.gov ID: NCT06100497
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for head and neck 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
- Patients with locally advanced (stage III to stage IVB) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) who meet the inclusion criteria will have their blood samples collected, tumor tissue samples or patient paraffin tissue, and slides for comprehensive genomic sequencing and analysis. The study is divided into two groups.
- 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 and older
You may be able to join if
- Patients with locally advanced (III-IVB) poorly differentiated head and neck tumors (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer...
- Patients who can receive systemic treatment or PD-1/L1 monotherapy before treatment;
- Patients in arm2 must be evaluated as having resectable tumors before treatment;
- The investigator believes that the patient can safely receive PD-1 combined with platinum-based and albumin-bound paclitaxel treatment;
- Age ≥ 18 years;
You likely can't join if
- Patients who have previously received PD-1/L1 combined chemotherapy drugs;
- Patients with a history of other malignant tumors (including unknown primary) within the past 5 years. Note: Excluding stage 1 or 2 skin...
- Patients who cannot tolerate postoperative radiotherapy;
- Patients known to be allergic to the study drug or its active ingredients or excipients;
- Patients with any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular...
- Patients with potential hematologic issues, including bleeding diathesis, known prior gastrointestinal bleeding requiring intervention within the...
See the full eligibility criteria
- Patients with locally advanced (III-IVB) poorly differentiated head and neck tumors (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer, nasal cavity and sinus cancer, excluding nasopharyngeal cancer) with a...
- Patients who can receive systemic treatment or PD-1/L1 monotherapy before treatment;
- Patients in arm2 must be evaluated as having resectable tumors before treatment;
- The investigator believes that the patient can safely receive PD-1 combined with platinum-based and albumin-bound paclitaxel treatment;
- Age ≥ 18 years;
- ECOG (Eastern Cooperative Oncology Group) 0-1；
- Measurable disease defined by RECIST v1.1;
- Adequate bone marrow reserve and organ function: absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8g/dL, no transfusion or erythropoietin (EPO) dependence (within 7 days of assessment);
- Renal function: serum creatinine ≤ 1.5X upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60mL/min, creatinine level \> 1.5X institutional ULN. (GFR can also be used instead of creatinine or...
- Liver function: For people with total bilirubin levels \>1.5 ULN, serum total bilirubin ≤1.5X ULN or direct bilirubin ≤ULN; For patients with liver metastasis, aspartate aminotransferase (AST/SGOT) and alanine...
- Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5X ULN, if people require anticoagulant therapy, PT or PTT (partial thromboplastin time) should be within the allowable range of...
- Women should agree to use contraception during the study and for 6 months after the end of the study (such as intrauterine devices (IUDs), contraceptive pills, or condoms); Within 7 days before study enrollment, serum...
- Patients who have previously received PD-1/L1 combined chemotherapy drugs;
- Patients with a history of other malignant tumors (including unknown primary) within the past 5 years. Note: Excluding stage 1 or 2 skin basal/squamous cell carcinoma or in situ carcinoma receiving potentially curative...
- Patients who cannot tolerate postoperative radiotherapy;
- Patients known to be allergic to the study drug or its active ingredients or excipients;
- Patients with any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction...
- Patients with potential hematologic issues, including bleeding diathesis, known prior gastrointestinal bleeding requiring intervention within the past 6 months, active pulmonary embolism or deep vein thrombosis (DVT)...
- History or evidence of active non-infectious pneumonia;
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. people with prior treated brain metastases may participate as long as they are stable (no evidence of...
- Within 7 days before the first day of the first cycle, at the same time (or receiving) treatment with drugs that may affect drug metabolism;
- Pregnant or breastfeeding, or expecting to become pregnant or give birth during the expected trial period;
- Any uncontrolled concurrent disease, including but not limited to persistent or active infection, symptomatic congestive heart failure, unstable angina, arrhythmia;
- Screening EKG\> 475 ms prolonged corrected QT (QTc) interval;
- Ejection fraction \<40% by 2D echocardiogram (ECHO) during screening;
- Any serious medical or mental illness/symptoms, including substance use disorders, may interfere with or limit compliance with study requirements/treatments in the investigator's judgment;
- Having active autoimmune diseases requiring systemic treatment in the past 2 years (even with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Alternative therapies (e.g., thyroid hormone...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.