Actively Recruiting
Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC
Led by Beijing Tongren Hospital · Updated on 2024-08-09
100
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Arm1 group: Patients with stage IVB (T4bNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 to 3 cycles (determined by the researcher based on tumor shrinkage). If the imaging achieves complete response (CR) or partial response (PR), suitable patients will undergo surgical treatment. Patients who are not suitable for surgery or have stable disease (SD)/progressive disease (PD) will receive concurrent chemoradiotherapy or concurrent chemoradiotherapy combined with PD-1 treatment (up to a total of 17 cycles). Arm2 group: Patients with stage III and IVA (T3NxM0, T4aNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 cycles. Patients who undergo surgery within 2 weeks will receive PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment based on pathological results. Patients who do not achieve pathological complete response (pCR) and have positive surgical margins or extracapsular extension will receive concurrent chemoradiotherapy followed by PD-1 maintenance treatment (up to a total of 17 cycles). Patients without high-risk factors will receive PD-1 maintenance treatment after radiotherapy (up to a total of 17 cycles). After completion of treatment, all patients will be followed up every 3 months for 1 year. Subsequently, patients will be followed up every 6 months for 3 years. Thereafter, patients will be followed up annually. Patient recurrence and survival data will be recorded.
CONDITIONS
Official Title
Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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) confirmed by histology or cytology
- Patients able to receive systemic treatment or PD-1/L1 monotherapy before treatment
- Patients in arm 2 must have resectable tumors before treatment
- Investigator believes patient can safely receive PD-1 combined with platinum-based and albumin-bound paclitaxel treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Measurable disease by RECIST v1.1
- Adequate bone marrow reserve and organ function (specified blood counts, hemoglobin, renal and liver function within defined limits)
- Coagulation function within acceptable limits; if on anticoagulants, PT or PTT within allowable range
- Women agree to use contraception during and for 6 months after the study; negative pregnancy test within 7 days before enrollment; non-lactating
- Men agree to use contraception during and for 6 months after the study
You will not qualify if you...
- Prior treatment with PD-1/L1 combined chemotherapy drugs
- History of other malignant tumors within the past 5 years, excluding certain early-stage skin cancers
- Unable to tolerate postoperative radiotherapy
- Known allergy to study drugs or their ingredients
- Unstable systemic diseases such as severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident, myocardial infarction, congestive heart failure
- Underlying immune deficiencies, chronic infections including HIV, hepatitis, tuberculosis, or autoimmune diseases
- Hematologic issues including bleeding disorders, recent gastrointestinal bleeding, active pulmonary embolism or deep vein thrombosis unstable on anticoagulation
- Active non-infectious pneumonia
- Active central nervous system metastases or carcinomatous meningitis; stable treated brain metastases allowed under conditions
- Use of drugs affecting drug metabolism within 7 days before first treatment
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Uncontrolled concurrent diseases including infection, symptomatic heart failure, unstable angina, arrhythmia
- Screening ECG with prolonged QT interval over 475 ms
- Ejection fraction less than 40% by echocardiogram
- Serious medical or mental illness that may interfere with study compliance
- Active autoimmune diseases requiring systemic treatment in past 2 years (replacement therapies excluded)
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, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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