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

Eye & ENT Hospital of Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Hypopharyngeal Carcinoma

Treatments: Radiation: Definitive radiotherapy; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Cisplatin; Procedure: Surgery with postoperative radiotherapy or chemoradiotherapy.; Drug: Finolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07248956

SOAR-HP

Details and patient eligibility

About

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

Full 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%).

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

neoadjuvant therapy followed by surgery and (C)RT group

Experimental group

Description:

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.

Treatment:

Drug: Finolizumab

Procedure: Surgery with postoperative radiotherapy or chemoradiotherapy.

Drug: Cisplatin

Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel

neoadjuvant therapy followed by CCRT group

Active Comparator group

Description:

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.

Treatment:

Drug: Finolizumab

Drug: Cisplatin

Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel

Radiation: Definitive radiotherapy