NCT06793761

A Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic LPSCC/HPSCC

A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic Laryngeal and Hypopharyngeal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, randomized controlled phase II study; Patients who met the inclusion criteria were divided into groups according to whether they had received radical radiotherapy or postoperative radiotherapy in the past. Group A was the group that had not received radiotherapy in the past, and Group B was the group that had received radiotherapy. Group A was randomly given 3 cycles of pembrolizumab + chemotherapy (see P22 for detailed chemotherapy regimen) in the experimental group at a 1:1 ratio, followed by surgery. After surgery, the patients were stratified according to whether there were high-risk factors. The high-risk group received concurrent chemoradiotherapy + pembrolizumab maintenance therapy (up to 15 cycles), and the low-risk group received radiotherapy + pembrolizumab maintenance therapy (up to 15 cycles). The control group underwent direct surgery and received concurrent chemoradiotherapy or radiotherapy after surgery. The total dose of radiotherapy was (high-risk group: 60-66Gy, 2Gy/time; low-risk group: 44-50 Gy, 2Gy/time) adjuvant therapy, and the radiotherapy time was within 2 months after surgery. Group B was randomly given 3 cycles of pembrolizumab + chemotherapy in the experimental group at a ratio of 1:1, followed by surgery and maintenance therapy with pembrolizumab after surgery (up to 15 cycles). The control group was given surgery directly, and observation/re-radiotherapy or chemoradiotherapy was chosen by the doctor after surgery. The total dose of radiotherapy was (56-60Gy, 2Gy/time), and the radiotherapy time was within 2 months after surgery. The enrolled patients must be closely monitored for adverse reactions to chemotherapy, and the time, grade, treatment measures, and outcomes must be recorded. All patients received an examination after the end of neoadjuvant therapy, an examination after surgery, and an examination at the 9th week after the first radiotherapy, and then reviewed every 3 months for 1 year; after 1 year, they were reviewed once every 6 months for 3 years; the recurrence and survival data of the patients were recorded.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200mg, IV, 3 cycles
DRUG	Cisplatin	cisplatin 75mg/m2, IV, 3 cycles
DRUG	Nab-paclitaxel	Nab-paclitaxel 260mg, IV, 3 cycles

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-12-20
• Completion: 2028-12-31
• First posted: 2025-01-27
• Last updated: 2025-01-27