Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC
NCT05272696 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2025-07-01
Summary
To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Guangdong Provincial People's Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-01
- Primary Completion
- 2026-01-01
- Completion
- 2026-01-01
Countries
- China
Study Locations
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