Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT05272696

Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC

Led by Guangdong Provincial People's Hospital · Updated on 2025-07-01

86

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.

CONDITIONS

Official Title

Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed locally advanced Head and Neck Squamous Cell Carcinoma (oral cavity, oropharynx, laryngeal, hypopharynx) stage III or IVA without metastasis, previously untreated
  • At least one measurable tumor lesion according to RECIST 1.1 criteria
  • ECOG performance status of 0 or 1
  • Men and women aged 18 to 70 years at informed consent
  • Adequate liver, heart, and kidney function as defined by specified blood counts and organ function tests
  • Female participants of childbearing potential must have a negative pregnancy test within 28 days before enrollment
  • Willingness to provide informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Active or suspected autoimmune disease, Type I diabetes, hypothyroidism requiring hormone replacement, or skin diseases needing systemic treatment
  • Systemic steroid therapy above 10 mg/day prednisone or equivalent within 14 days before enrollment
  • Known active Hepatitis B, Hepatitis C, or HIV infection
  • Active pulmonary tuberculosis
  • Severe heart diseases including congestive heart failure, unstable angina, high-risk arrhythmias, myocardial infarction, or uncontrollable hypertension
  • Pregnant or breastfeeding women
  • Fertile patients unwilling or not using effective contraception
  • Participation in another investigational study or use of investigational devices
  • History of other invasive malignancies or unresectable cancer
  • Receipt of live vaccine within 30 days before starting study therapy
  • Any condition or abnormality that might interfere with study participation or results as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

H

Haiqing Ma

CONTACT

S

Siyi Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC | DecenTrialz