Neoadjuvant chemotherapy combined with immunotherapy has achieved promising pathological remission rates in locally advanced head and neck squamous cell carcinoma and has offered new hope for patients with locally advanced laryngeal and hypopharyngeal cancer. In our center's previous phase II study on locally advanced laryngeal and hypopharyngeal cancer, neoadjuvant chemotherapy combined with immunotherapy showed good 1 - year laryngeal preservation rate and 1 - year PFS rate. However, in locally advanced laryngeal and hypopharyngeal cancer, whether neoadjuvant chemotherapy combined with PD-1 inhibitor, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival, event - free survival and overall survival remains unclear.
Thus, this study aims to explore in locally advanced laryngeal and hypopharyngeal cancer whether neoadjuvant immuno - chemotherapy, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival and bring benefits in quality of life.
Patients who have signed the informed consent form and are willing to complete the study according to the protocol.
Age ≥18 years and ≤75 years.
Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx.
Locally advanced laryngeal or hypopharyngeal cancer that requires total laryngectomy and is amenable to total laryngectomy according to surgical assessment.
Patients who have been confirmed to have distant metastasis on imaging assessment before treatment.
Patients who have previously received immune checkpoint inhibitor therapy.
Patients who have previously received radiotherapy to the head and neck region.
Patients who have had or currently have other malignancies (except for malignancies that have been cured and have been cancer-free for more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer); if a patient has both hypopharyngeal cancer and esophageal cancer, and the esophageal lesion and hypopharyngeal lesion are anatomically non-adjacent, they should be diagnosed with multiple primary tumors and will not be eligible for enrollment.
Parallel
Neoadjuvant Chemotherapy (NACT)
DrugNeoadjuvant Chemotherapy with paclitaxel (or albumin - bound paclitaxel) and cisplatin
Neoadjuvant and maintenance Tislelizumab
DrugNeoadjuvant and maintenance Tislelizumab
Concurrent chemo-radiotherapy (CCRT)
RadiationConcurrent chemo-radiotherapy (CCRT), with cisplatin-based chemotherapy
Surgery and adjuvant (chemo-)radiotherapy
Procedure/SurgeryDefinitive surgery, with adjuvant (chemo-)radiotherapy, depending on pathologic findings.
2-year Laryngectomy-free Survival Rate
Laryngectomy-free survival (LFS) is defined as the time from randomization to the first occurrence of local recurrence, total laryngectomy, or death, with the time calculated based on the first event that occurs.
Early response rate
Early response rate is defined as the proportion of patients achieving a complete response \[CR\] or partial response \[PR\] in the primary tumor after one cycle of neoadjuvant therapy
Objective response rate to neoadjuvant therapy
Objective response rate to neoadjuvant therapy is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) in the primary tumor and cervical lymph nodes after three cycles of neoadjuvant therapy.
2-year Event-free Survival Rate
Event-free survival (EFS), defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local recurrence, distant metastasis, or death from any cause, whichever occurs first.
2-year Overall Survival Rate
Overall Survival (OS), defined as the time from randomization to death from any cause.
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Fudan University
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
Fujian Cancer Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
