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

NCT07248956 | Recruiting Phase 2 DMC

• 1 other identifier: SOAR-HP
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Hypopharyngeal Carcinoma

Keywords

PD-1 inhibitor; neoadjuvant therapy; locally advanced

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  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 Outcomes (5)

• Overall Survival (OS)

  2 years

• Locoregional Control Rate (LRFS)

  2 years

• Laryngeal Preservation Rate

  2 years

• Major Pathological Response Rate (MPR)

  2 years

• Adverse events

  2 years

Study Arms (2)

neoadjuvant therapy followed by surgery and (C)RT group

EXPERIMENTAL

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

neoadjuvant therapy followed by CCRT group

ACTIVE COMPARATOR

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; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Cisplatin; Radiation: Definitive radiotherapy

Interventions

Finolizumab DRUG

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

neoadjuvant therapy followed by CCRT group; neoadjuvant therapy followed by surgery and (C)RT group

Albumin-Bound Paclitaxel /nab-Paclitaxel DRUG

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

neoadjuvant therapy followed by CCRT group; neoadjuvant therapy followed by surgery and (C)RT group

Cisplatin DRUG

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

neoadjuvant therapy followed by CCRT group; neoadjuvant therapy followed by surgery and (C)RT group

Definitive radiotherapy RADIATION

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

neoadjuvant therapy followed by CCRT group

Surgery with postoperative radiotherapy or chemoradiotherapy. PROCEDURE

surgery with postoperative radiotherapy or chemoradiotherapy.

neoadjuvant therapy followed by surgery and (C)RT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (7)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

Shandong Provincial ENT Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Beijing Tongren Hospital, Capital Medical University

Beijing, China

NOT YET RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

NOT YET RECRUITING

Eye & ENT Hospital, Fudan University

Shanghai, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

NOT YET RECRUITING

MeSH Terms

Conditions

Hypopharyngeal Neoplasms

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Cisplatin; Surgical Procedures, Operative; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Ming Zhang, PhD

  Eye & ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiyao Hsueh

CONTACT

021-64377134; hsuehchiyao@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)