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RECRUITING
NCT06102395
PHASE3

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

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

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

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

Locations (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China