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This is a multi-center, randomized controlled, prospective clinical study.
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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant therapy followed by surgery and (C)RT group | Experimental | Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy. |
|
| neoadjuvant therapy followed by CCRT group | Active Comparator | Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finolizumab | Drug | 200mg every 3 weeks (q3w) for 2 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Duration from the date of tumor treatment initiation to the date of first documented death from any cause or the last follow-up date. | 2 years |
| Locoregional Control Rate (LRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiyao Hsueh | Contact | 021-64377134 | hsuehchiyao@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zhang, PhD | Eye & ENT Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | China |
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| Albumin-Bound Paclitaxel /nab-Paclitaxel | Drug | 260mg/m², day 1, every 3 weeks (q3w) for 2 cycles. |
|
| Cisplatin | Drug | 25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles. |
|
| Definitive radiotherapy | Radiation | Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks) |
|
| Surgery with postoperative radiotherapy or chemoradiotherapy. | Procedure | surgery with postoperative radiotherapy or chemoradiotherapy. |
|
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.
| 2 years |
| Laryngeal Preservation Rate | The proportion of patients who successfully retain laryngx function after treatment. | 2 years |
| Major Pathological Response Rate (MPR) | The presence of ≤10% viable invasive squamous cell carcinoma in the resected primary tumor and neck lymph nodes. | 2 years |
| Adverse events | 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. | 2 years |
| Shandong Provincial ENT Hospital | Not yet recruiting | Jinan | Shandong | China |
|
| Beijing Tongren Hospital, Capital Medical University | Not yet recruiting | Beijing | China |
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| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | China |
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| Eye & ENT Hospital, Fudan University | Recruiting | Shanghai | China |
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| Zhongshan Hospital of Fudan University | Not yet recruiting | Shanghai | China |
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| Tianjin Medical University Cancer Institute & Hospital | Not yet recruiting | Tianjin | China |
|
| ID | Term |
|---|---|
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D013514 | Surgical Procedures, Operative |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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