Hypopharyngeal Carcinoma
Conditions
Keywords
PD-1 inhibitor, neoadjuvant therapy, locally advanced
Brief summary
This is a multi-center, randomized controlled, prospective clinical study.
Detailed description
The early symptoms of hypopharyngeal cancer are often inconspicuous, with approximately 70% of patients clinically diagnosed at an advanced stage. With the emergence of immunotherapy, immune therapies such as PD-1 inhibitors combined with induction chemotherapy have been widely explored in various tumor types. Currently, there is a lack of large-scale real-world studies on the efficacy and safety of treatment options for patients with locally advanced hypopharyngeal cancer who respond well to neoadjuvant therapy. This study aims to employ neoadjuvant chemotherapy combined with immunotherapy for locally advanced hypopharyngeal cancer and explore the effectiveness and safety of different subsequent treatment options for patients assessed as achieving a major partial response (PR ≥50%).
Interventions
260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
DRUGFinolizumab
200mg every 3 weeks (q3w) for 2 cycles.
DRUGCisplatin
25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
RADIATIONDefinitive radiotherapy
Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)
PROCEDURESurgery with postoperative radiotherapy or chemoradiotherapy.
surgery with postoperative radiotherapy or chemoradiotherapy.
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Willingness to provide written informed consent; 2. Age ≥18 and ≤75 years; 3. Treatment-naïve for malignant disease; 4. Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ; 5. ECOG performance status 0-2.
Exclusion criteria
1. Pregnancy or breastfeeding status; 2. Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components; 3. Poorly controlled cardiovascular conditions or other diseases; 4. Active or documented history of autoimmune diseases requiring systemic treatment; 5. Synchronous or metachronous malignancies; 6. Other conditions deemed ineligible for the study by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | 2 years | Duration from treatment initiation until the first occurrence of any of the following events: disease progression precluding surgical intervention, local or distant recurrence, death from any cause, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 2 years | Duration from the date of tumor treatment initiation to the date of first documented death from any cause or the last follow-up date. |
| Locoregional Control Rate (LRFS) | 2 years | Duration from the date of tumor treatment initiation to the date of first documented locoregional recurrence, death from any cause, or the last follow-up date. |
| Laryngeal Preservation Rate | 2 years | The proportion of patients who successfully retain laryngx function after treatment. |
| Major Pathological Response Rate (MPR) | 2 years | The presence of ≤10% viable invasive squamous cell carcinoma in the resected primary tumor and neck lymph nodes. |
| Adverse events | 2 years | Acute treatment-related toxicities were evaluated using CTCAE v5.0 (Common Terminology Criteria for Adverse Events, Version 5.0), with patient counts reported for each AE category. Late radiation toxicities were assessed per the RTOG (Radiation Therapy Oncology Group) grading criteria, with both patient numbers and incidence rates documented. |
Countries
China
Contacts
Primary ContactChiyao Hsueh
Outcome results
None listed