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

Phase 2RecruitingNCT07248956

Eye & ENT Hospital of Fudan University116 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Hypopharyngeal Carcinoma

Interventions

FinolizumabDRUG

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

Albumin-Bound Paclitaxel /nab-PaclitaxelDRUG

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

CisplatinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Overall Survival (OS)

Duration from the date of tumor treatment initiation to the date of first documented death from any cause or the last follow-up date.

Time frame: 2 years

Locoregional Control Rate (LRFS)

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.

Time frame: 2 years

Laryngeal Preservation Rate

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

Time frame: 2 years

Major Pathological Response Rate (MPR)

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

Time frame: 2 years

Adverse events

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.

Time frame: 2 years

Central Contacts

Chiyao Hsueh

CONTACT

021-64377134 hsuehchiyao@gmail.com

Data from ClinicalTrials.gov

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