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
Beijing Tongren Hospital
272 participants
May 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Pembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle
Cisplatin 75 mg/m\^2, IV, day 1 of Q3W
Carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W
Nedaplatin 80-100 mg/m\^2, IV, day 2-4 of Q3W
Nab paclitaxel 260 mg/m\^2, IV, day 1 of Q3W
Docetaxel 75 mg/m\^2, IV, day 1 of Q3W
Liposomal paclitaxel 135-175 mg/m\^2, IV, day 1 of Q3W
Fluorouracil 750 mg/m\^2, IV, day 1-5 of Q3W
Locations(1)
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NCT06102395