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Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
Sponsor: Beijing Tongren Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
272
Start Date
2023-05-01
Completion Date
2030-04-30
Last Updated
2023-10-30
Healthy Volunteers
No
Interventions
Pembrolizumab
Pembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle
Cisplatin
Cisplatin 75 mg/m\^2, IV, day 1 of Q3W
Carboplatin
Carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W
Nedaplatin
Nedaplatin 80-100 mg/m\^2, IV, day 2-4 of Q3W
Nab paclitaxel
Nab paclitaxel 260 mg/m\^2, IV, day 1 of Q3W
Docetaxel
Docetaxel 75 mg/m\^2, IV, day 1 of Q3W
Liposomal paclitaxel
Liposomal paclitaxel 135-175 mg/m\^2, IV, day 1 of Q3W
Fluorouracil
Fluorouracil 750 mg/m\^2, IV, day 1-5 of Q3W
Locations (1)
Beijing Tongren Hospital
Beijing, Beijing Municipality, China