To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Pembrolizumab in combination with Nab-paclitaxel and cisplatin as induction therapy
Patients with PR but the maximum diameter of tumor \> 3cm or SD or PD can receive surgery directly.
After surgery, adjuvant Chemoradiotherapy or radiotherapy will be given for patients with high-risk factors.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGObjective response rate
Objective response rate (ORR) will be determinated by evaluation of Complete Response (CR) and Partial Response (PR)
Time frame: 24 months
Evaluation of Safety
Toxicity will be evaluated according to NCI-CTCAE v4.03
Time frame: 24 months
Rate of organ preservation
After two courses of induction treatment, MDT discussed whether to accept surgical treatment or concurrent chemoradiotherapy, and the proportion of patients whose organ function can be preserved after treatment.
Time frame: 24 months
overall survival (OS)
Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time frame: 24 months
progression-free survival (PFS)
Defined from date of registration to date of first documentation of progression or death due to any cause.
Time frame: 24 months
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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.