Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC
To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.
| Condition(s) | Head and Neck Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC. |
| Who can participate | Inclusion Criteria: 1. Histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma (oral cavity, oropharynx, laryngeal and hypopharynx) with locoregionally-advanced disease stage III or IVA without metastasis , previously untreated (AJCC 8th) and had at least one tumour lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 2. Measurable disease based on RECIST 1.1 3. ECOG performance status 0-1 4. Men and women, Age ≥18 and ≤ 70 years at the time of signing informed consent, 5. Adequate hepatic, cardiac and renal function as demonstrated by 1) Hematology: ANC≥1.5×10\^9 /L, HGB≥9 g/dL, PLT≥80×10\^9 /L; 2) Renal: Serum creatinine \< 1.5x ULN or CrCl \> 60mL/min; 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN and ALP≤5 x ULN. |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Guangdong Provincial People's Hospital |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2022-03-01 |
| NCT ID | NCT05272696 |
| Official listing | https://clinicaltrials.gov/study/NCT05272696 |