RecruitingPhase 3NCT06102395

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


Sponsor

Beijing Tongren Hospital

Enrollment

272 participants

Start Date

May 1, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding pembrolizumab (an immunotherapy drug) to standard chemotherapy before surgery or definitive treatment can improve outcomes for people with locally advanced head and neck squamous cell carcinoma (HNSCC). It compares immunotherapy plus chemo against chemotherapy alone as an initial (neoadjuvant) treatment. **You may be eligible if...** - You are 18 years or older - You have been confirmed by biopsy to have Stage IIIA–IVB head and neck squamous cell carcinoma - You have not previously received immunotherapy - Your ECOG performance status is 0–2 - You have measurable disease on imaging - Your organ functions (blood, liver, kidneys) are adequate **You may NOT be eligible if...** - Your cancer has already spread to distant parts of the body (distant metastases) - You are pregnant - You have received a live vaccine in the past 30 days - You have immunodeficiency or are on systemic immunosuppression - You have active brain metastases - You have had a prior organ or tissue transplant Talk to your doctor to see if this trial is right for you.

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

DRUGPembrolizumab

Pembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle

DRUGCisplatin

Cisplatin 75 mg/m\^2, IV, day 1 of Q3W

DRUGCarboplatin

Carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W

DRUGNedaplatin

Nedaplatin 80-100 mg/m\^2, IV, day 2-4 of Q3W

DRUGNab paclitaxel

Nab paclitaxel 260 mg/m\^2, IV, day 1 of Q3W

DRUGDocetaxel

Docetaxel 75 mg/m\^2, IV, day 1 of Q3W

DRUGLiposomal paclitaxel

Liposomal paclitaxel 135-175 mg/m\^2, IV, day 1 of Q3W

DRUGFluorouracil

Fluorouracil 750 mg/m\^2, IV, day 1-5 of Q3W


Locations(1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

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NCT06102395


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