MedTrace Logo

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

NCT06102395 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2023-10-30

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Zhigang Huang · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2027-04-30
Completion
2030-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06102395 on ClinicalTrials.gov