This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The immunotherapy drug was pembrolizumab at a dose of 200 mg, administered on the first day of each cycle every 3 weeks. The induction chemotherapy regimen included albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every 3 weeks, either concurrently with immunotherapy or on the second day.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival (PFS)
Progression-free survival (PFS) (local-regional recurrence) is defined as the time from enrollment to the occurrence of local or regional lymph node recurrence or death for any reason.
Time frame: 1 year
Overall survival (OS)
Overall survival is defined as the time from enrollment to death for any reason
Time frame: 3-year
Clinical response rate
Clinical response is defined as the radiological evaluation of tumor regression as partial remission (PR) and complete remission (CR) on imaging assessment three months after the completion of treatment.
Time frame: 6 months
Safety(Grade 3-5 AE)
Safety is primarily assessed based on the probability of occurrence of Grade 3-5 adverse effects in different organs according to CTCAE 4.0 (including radiation-related injuries and adverse reactions to immunotherapy).
Time frame: 1-year
Quality of life
The assessment of quality of life is conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Module (EORTC QLQ-H\&N 35), which includes eight domains: pain, swallowing, senses, speech, social eating, social contact, sexuality and single items. Each item is scored on a scale from 0 to 100. A high score for a functional scale or global QOL implies a high level of functioning or global QOL, whereas a high score for a symptom scale or single item implies a high level of symptoms.
Time frame: 6 month and 1 year after the treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.