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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC
ClinicalTrials.gov ID: NCT06725498
What this study is testing
What is Tislelizumab-jsgr?
Tislelizumab-jsgr is an investigational medicine, given as an infusion into a vein, 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
- This study pioneers a novel approach by integrating a new auxiliary chemo-immunotherapy regimen, which is then followed by an evaluation of the potential for surgical resection. For those patients who remain non-resectable, a tailored treatment plan is proposed, consisting of arterial infusion chemotherapy in conjunction with radiotherapy, succeeded by a series of immune checkpoint inhibitors.
- 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 T4bNanyM0 Head and neck squamous cell carcinoma (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer or oral cavity) with a...
- Expected survival ≥3 months, with adequate organ function;
- Investigators believe they can safely receive treatment with PD-1 combined with platinum and albumin-bound paclitaxel;
- Age ≥18 years;
- ECOG score of 0-1;
You likely can't join if
- Patients with a history of prior immunotherapy, radiotherapy, and treatment with EGFR monoclonal antibodies;
- Patients with a history of other (including unknown primary) malignant tumors within the past 5 years;
- Patients who are intolerant to radiotherapy post-surgery;
- Patients known to be allergic to the study medication or its active ingredients, excipients;
- Patients with any unstable systemic diseases, including but not limited to: severe infections, uncontrolled diabetes, unstable angina...
- Patients with potential immune deficiencies, chronic infections, including HIV, hepatitis, tuberculosis (TB), or autoimmune diseases;
See the full eligibility criteria
- Patients with T4bNanyM0 Head and neck squamous cell carcinoma (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer or oral cavity) with a confirmed diagnosis by histology and/or cytology;
- Expected survival ≥3 months, with adequate organ function;
- Investigators believe they can safely receive treatment with PD-1 combined with platinum and albumin-bound paclitaxel;
- Age ≥18 years;
- ECOG score of 0-1;
- Measurable disease as defined by RECIST v1.1;
- Adequate bone marrow reserve and organ function: Absolute neutrophil count (ANC) ≥1,000/microliter (mcL), platelets ≥75,000/mcL, hemoglobin ≥8g/dL, without transfusion or dependence on erythropoietin (EPO) (within 7...
- Renal function: Serum creatinine ≤1.5 times the upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥60mL/min with creatinine levels \> 1.5 times the institutional ULN. (GFR can also be used in...
- Liver function: For people with a total bilirubin level \>1.5 ULN, serum total bilirubin ≤1.5 times ULN or direct bilirubin ≤ULN; For patients with liver metastases, aspartate aminotransferase (AST/SGOT) and alanine...
- Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, if the subject is receiving anticoagulant therapy, PT or PTT should be within the permissible range of the...
- Females should agree to use contraceptive measures (such as intrauterine device (IUD), oral contraceptives, or condoms) during the study and for 6 months after the study ends; Negative serum or urine pregnancy test...
- Patients with a history of prior immunotherapy, radiotherapy, and treatment with EGFR monoclonal antibodies;
- Patients with a history of other (including unknown primary) malignant tumors within the past 5 years;
- Patients who are intolerant to radiotherapy post-surgery;
- Patients known to be allergic to the study medication or its active ingredients, excipients;
- Patients with any unstable systemic diseases, including but not limited to: severe infections, uncontrolled diabetes, unstable angina, cerebrovascular accidents or transient ischemic attacks, myocardial infarction...
- Patients with potential immune deficiencies, chronic infections, including HIV, hepatitis, tuberculosis (TB), or autoimmune diseases;
- Patients with potential hematological issues, including bleeding disorders, known prior gastrointestinal bleeding requiring intervention within the past 6 months, active pulmonary embolism or deep vein thrombosis (DVT)...
- A history or any evidence of active noninfectious pneumonia;
- Known active central nervous system (CNS) metastases and/or leptomeningeal disease or carcinomatous meningitis. people with previously treated brain metastases may participate if they are stable (no evidence of imaging...
- Concurrent use (or receipt) of medications within 7 days prior to Day 1 of Cycle 1 that may affect drug metabolism;
- Pregnant or breastfeeding, or expecting to become pregnant or father a child during the anticipated trial period;
- Any uncontrollable concomitant diseases, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias;
- Prolonged corrected QT (QTc) interval \> 475 ms on screening EKG;
- Ejection fraction \<40% on 2D echocardiogram (ECHO) at screening;
- Any serious medical or psychiatric illness/condition, including substance use disorders, that may interfere with or limit adherence to study requirements/treatment in the investigator's judgment;
- Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapies (e.g., thyroid hormone, insulin...
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.