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NCT Number: NCT07248956

Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma

This is a multi-center, randomized controlled, prospective clinical study.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

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About this 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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness to provide written informed consent;
  • Age ≥18 and ≤75 years;
  • Treatment-naïve for malignant disease;
  • Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;
  • ECOG performance status 0-2.

Exclusion criteria

  • Pregnancy or breastfeeding status;
  • Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;
  • Poorly controlled cardiovascular conditions or other diseases;
  • Active or documented history of autoimmune diseases requiring systemic treatment;
  • Synchronous or metachronous malignancies;
  • Other conditions deemed ineligible for the study by investigators.

Treatment and study plan

Finolizumab

Drug

200mg every 3 weeks (q3w) for 2 cycles.

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.

Primary outcomes

  1. Event-free survival (EFS)

    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.

Secondary outcomes

  1. Overall Survival (OS)

    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.

  2. Locoregional Control Rate (LRFS)

    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.

  3. Laryngeal Preservation Rate

    Time frame: 2 years

    The proportion of patients who successfully retain laryngx function after treatment.

  4. Major Pathological Response Rate (MPR)

    Time frame: 2 years

    The presence of ≤10% viable invasive squamous cell carcinoma in the resected primary tumor and neck lymph nodes.

  5. Adverse events

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiyao Hsueh

CONTACT

[email protected]

021-64377134

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Nov 25, 2025
Registry last updated
Dec 23, 2025

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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