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

December 22, 2025 updated by: Ming Zhang, Eye & ENT Hospital of Fudan University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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%).

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
      • Beijing, China
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Shanghai, China
        • Recruiting
        • Eye & ENT Hospital, Fudan University
        • Contact:
          • Ming Zhang, PhD
          • Phone Number: 8621-64377151
          • Email: zmzlm@163.com
      • Shanghai, China
      • Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Provincial ENT Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neoadjuvant therapy followed by surgery and (C)RT group
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.
Drug: Finolizumab
200mg every 3 weeks (q3w) for 2 cycles.
Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel
260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
Drug: Cisplatin
25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
Procedure: Surgery with postoperative radiotherapy or chemoradiotherapy.
surgery with postoperative radiotherapy or chemoradiotherapy.
Active Comparator: neoadjuvant therapy followed by CCRT group
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.
Drug: Finolizumab
200mg every 3 weeks (q3w) for 2 cycles.
Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel
260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
Drug: Cisplatin
25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
Radiation: Definitive radiotherapy
Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
Laryngeal Preservation Rate
Time Frame: 2 years
The proportion of patients who successfully retain laryngx function after treatment.
2 years
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.
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Ming Zhang, PhD, Eye & ENT Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOAR-HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypopharyngeal Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe