NCT05272696

Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC

Induction Therapy With Nab-paclitaxel, Cisplatin and Pembrolizumab in Untreated Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.

Detailed description

This study is a non-randomized, single-arm, single-institutional phase II study including patients with Locally Advanced Head and Neck Squamous Cell Carcinoma eligible for resection. Nab-paclitaxel (260 mg/m² IV), cisplatin (75 mg/m² IV), and Pembrolizumab (200 mg IV) will be administered for two cycles of three weeks duration each. Surgery or CRT will be performed after induction therapy. Patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive CRT. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment. Patients with PR but the maximum diameter of tumor \> 3cm or SD or PD can receive surgery directly. After surgery, adjuvant CRT will be given for patients with high-risk factors. Objective response rate, safety, and rate of organ preservation will be the primary outcome measures.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel, cisplatin and Pembrolizumab combination	Pembrolizumab in combination with Nab-paclitaxel and cisplatin as induction therapy
PROCEDURE	surgery	Patients with PR but the maximum diameter of tumor \> 3cm or SD or PD can receive surgery directly.
RADIATION	Adjuvant Chemoradiotherapy	After surgery, adjuvant Chemoradiotherapy or radiotherapy will be given for patients with high-risk factors.
DRUG	Radical concurrent chemoradiotherapy	Patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive Radical concurrent chemoradiotherapy. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment.

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-03-09
• Last updated: 2025-07-01

Locations

1 site across 1 country: China