A Phase 2 interventional study of Nab-paclitaxel, cisplatin and Pembrolizumab combination and surgery in Head and Neck Squamous Cell Carcinoma, sponsored by Guangdong Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Guangdong Provincial People's Hospital · Phase 2, Interventional, and Treatment
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 86 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All enrolled patients will receive two cycles of chemotherapy consisting of nab-paclitaxel (260 mg/m² on days 1), cisplatin (75 mg/m² on days 1), and Pembrolizumab (200 mg on days 1). Each cycle is repeated every 21 days. After induction therapy, 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. 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.
Drug: Nab-paclitaxel, cisplatin and Pembrolizumab combination · Procedure: surgery · Radiation: Adjuvant Chemoradiotherapy · Drug: Radical concurrent chemoradiotherapy
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.
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.
Objective 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
Plan to share: No
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Squamous Cell Carcinoma of Head and Neck→
Guangdong Provincial People's Hospital