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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2029-12-30

Brief Summary

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

Detailed Description

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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%).

Conditions

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Hypopharyngeal Carcinoma

Keywords

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PD-1 inhibitor neoadjuvant therapy locally advanced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Finolizumab

Intervention Type DRUG

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

Albumin-Bound Paclitaxel /nab-Paclitaxel

Intervention Type DRUG

260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.

Cisplatin

Intervention Type DRUG

25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.

Surgery with postoperative radiotherapy or chemoradiotherapy.

Intervention Type PROCEDURE

surgery with postoperative radiotherapy or chemoradiotherapy.

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.

Group Type ACTIVE_COMPARATOR

Finolizumab

Intervention Type DRUG

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

Albumin-Bound Paclitaxel /nab-Paclitaxel

Intervention Type DRUG

260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.

Cisplatin

Intervention Type DRUG

25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.

Definitive radiotherapy

Intervention Type RADIATION

Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)

Interventions

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Finolizumab

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

Intervention Type DRUG

Albumin-Bound Paclitaxel /nab-Paclitaxel

260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.

Intervention Type DRUG

Cisplatin

25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.

Intervention Type DRUG

Definitive radiotherapy

Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)

Intervention Type RADIATION

Surgery with postoperative radiotherapy or chemoradiotherapy.

surgery with postoperative radiotherapy or chemoradiotherapy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ming Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Eye & ENT Hospital, Fudan University

Locations

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