Actively Recruiting
Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC
Led by Beijing Tongren Hospital · Updated on 2024-12-10
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The efficacy and safety of this integrated therapeutic strategy are meticulously assessed, with the goal of enhancing survival outcomes for patients with T4bNanyM0 HNSCC.
CONDITIONS
Official Title
Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of T4bNanyM0 head and neck squamous cell carcinoma confirmed by histology or cytology
- Expected survival of at least 3 months with adequate organ function
- Able to safely receive PD-1 inhibitor combined with platinum and albumin-bound paclitaxel
- Age 18 years or older
- ECOG performance status of 0 to 1
- Measurable disease per RECIST v1.1 criteria
- Adequate bone marrow reserve: ANC 61,000/mcL, platelets 675,000/mcL, hemoglobin 68 g/dL without transfusion or erythropoietin dependence within 7 days
- Renal function: serum creatinine 61.5 times upper limit of normal or creatinine clearance 60 mL/min
- Liver function: total bilirubin 61.5 times upper limit of normal or direct bilirubin 61 times upper limit, AST/ALT 62.5 or 65 times upper limit if liver metastases, albumin E 2.5 mg/dL
- Coagulation function: INR or prothrombin time 61.5 times upper limit of normal, stable if on anticoagulants
- Females must use contraception during and for 6 months after the study and have a negative pregnancy test within 7 days before entry
- Males must agree to use contraception during and for 6 months after the study
You will not qualify if you...
- Prior immunotherapy, radiotherapy, or treatment with EGFR monoclonal antibodies
- Other malignant tumors within the past 5 years
- Intolerance to radiotherapy after surgery
- Allergy to study drugs or their components
- Unstable systemic diseases such as severe infections, uncontrolled diabetes, heart conditions, liver, kidney, or metabolic disorders
- Immune deficiencies or chronic infections including HIV, hepatitis, tuberculosis, or autoimmune diseases
- Hematological problems including bleeding disorders, recent gastrointestinal bleeding, unstable pulmonary embolism or deep vein thrombosis
- History or evidence of active noninfectious pneumonia
- Active central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed)
- Use of medications affecting drug metabolism within 7 days before treatment
- Pregnancy, breastfeeding, or planning pregnancy during the trial
- Uncontrollable infections, symptomatic heart failure, unstable angina, arrhythmias
- Prolonged QT interval >475 ms on screening EKG
- Ejection fraction <40% on screening echocardiogram
- Serious medical or psychiatric conditions affecting study adherence
- Active autoimmune disease requiring systemic treatment in the past 2 years (replacement therapies allowed)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 10000
Actively Recruiting
Research Team
X
Xiaohong Chen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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