Finolizumab
Drug200mg every 3 weeks (q3w) for 2 cycles.
NCT Number: NCT07248956
This is a multi-center, randomized controlled, prospective clinical study.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
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%).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200mg every 3 weeks (q3w) for 2 cycles.
260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)
surgery with postoperative radiotherapy or chemoradiotherapy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
The proportion of patients who successfully retain laryngx function after treatment.
Time frame: 2 years
The presence of ≤10% viable invasive squamous cell carcinoma in the resected primary tumor and neck lymph nodes.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Eye & ENT Hospital of Fudan University
Other
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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