NCT06102395

Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC

EFFECT-neo: A Prospective, Open-label, Multicenter Phase III Study to Evaluate Efficacy and Safety of Pembrolizumab Combined With Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, multi-center phase III study; patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+ chemotherapy for 2 cycles (experimental group), 2 cycles of chemotherapy (control group), and then stratified according to the patient's condition. If the imaging evaluation after neoadjuvant treatment is (complete response, CR), adjuvant radiotherapy will be given; if the imaging evaluation is (partial response, PR) or (stable disease, SD), surgery (within 2 weeks) will be performed, followed by standard treatment. The main research hypothesis of this study: pembrolizumab combined with standard chemotherapy can significantly improve the rate of pathological complete response (pCR) compared with standard chemotherapy.

Detailed description

This study is a prospective, open-label, multi-center phase III study; Patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who met the inclusion criteria were randomized in a 1:1 ratio and given 2 cycles of pembrolizumab 200 mg d1 + chemotherapy (see the table below for detailed chemotherapy regimens) (experimental group) and 2 cycles of chemotherapy (control group), and were divided according to the patient's condition. layer. If the imaging evaluation is CR after neoadjuvant treatment, radiotherapy (60-70Gy) ± chemotherapy (investigator's choice) will be given as adjuvant treatment; if the imaging evaluation is PR or SD, surgery (within 2 weeks) will be performed, and then standard treatment will be given. treat. If the imaging evaluation is PD, standard treatment will be given. Enrolled patients must closely monitor the adverse reactions of chemotherapy and record the time, grade, treatment measures, outcomes, etc. All patients were reviewed every 3 months for 1 year; after 1 year, they were reviewed every 6 months for 3 years; patient recurrence and survival data were recorded. The investigators speculate that, compared with the traditional induction chemotherapy regimen, the induction chemotherapy regimen of pembrolizumab combined with chemotherapy may be safer and more effective, and easier for clinical application. At present, there are no research reports on the induction chemotherapy of pembrolizumab combined with cisplatin and nab-paclitaxel for patients with locally advanced operable head and neck squamous cell carcinoma. We intend to conduct a randomized controlled study on the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in Chinese patients with operable head and neck squamous cell carcinoma, and provide a basis for the neoadjuvant therapy of pembrolizumab combined with chemotherapy.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Neoadjuvant Therapy
• Pembrolizumab

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle
DRUG	Cisplatin	Cisplatin 75 mg/m\^2, IV, day 1 of Q3W
DRUG	Carboplatin	Carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W
DRUG	Nedaplatin	Nedaplatin 80-100 mg/m\^2, IV, day 2-4 of Q3W
DRUG	Nab paclitaxel	Nab paclitaxel 260 mg/m\^2, IV, day 1 of Q3W
DRUG	Docetaxel	Docetaxel 75 mg/m\^2, IV, day 1 of Q3W
DRUG	Liposomal paclitaxel	Liposomal paclitaxel 135-175 mg/m\^2, IV, day 1 of Q3W
DRUG	Fluorouracil	Fluorouracil 750 mg/m\^2, IV, day 1-5 of Q3W

Timeline

• Start date: 2023-05-01
• Primary completion: 2027-04-30
• Completion: 2030-04-30
• First posted: 2023-10-26
• Last updated: 2023-10-30

Locations

1 site across 1 country: China