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A multicenter clinical trial of neoadjuvant therapy with PD-1 inhibitors combined with chemotherapy for preserving laryngeal function in locally advanced hypopharyngeal cancer

A multicenter clinical trial of neoadjuvant therapy with PD-1 inhibitors combined with chemotherapy for preserving laryngeal function in locally advanced hypopharyngeal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113521
Enrollment
Unknown
Registered
2025-12-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopharyngeal squamous cell carcinoma

Interventions

Experimental group:Receive two courses of neoadjuvant therapy with PD-1 inhibitors combined with chemotherapy

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age >=18 years old; 2) The pathological diagnosis is hypopharyngeal squamous cell carcinoma.; 3) At the initial diagnosis, it was stage T3-4 hypopharyngeal squamous cell carcinoma (according to AJCC 8th Edition); 4) Agree to receive PD-1 inhibitor immunotherapy combined with chemotherapy as neoadjuvant therapy, followed by surgical treatment.

Exclusion criteria

Exclusion criteria: 1) Has undergone surgery, radiotherapy, chemotherapy, immunotherapy or targeted therapy in the past; 2) There is distant metastasis or recurrence; 3) Combined with other primary malignant tumors.

Design outcomes

Primary

MeasureTime frame
The pathological response rate of locally advanced hypopharyngeal carcinoma: including significant pathological response (MPR) and complete pathological response (pCR);

Secondary

MeasureTime frame
Two-year lung survival rate (LFS);Two-year overall survival (OS) rate;Two-year progression-free survival (PFS) rate;

Countries

China

Contacts

Public ContactCai Qian

Zhujiang Hospital of Southern Medical University

caiq163@126.com+86 137 1070 9975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026