RecruitingPhase 2NCT05758389

Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors

A Prospective Single-center, Single-arm Clinical Study of the PD-1 Inhibitor Tislelizumab Combined With APF Sequential Surgery or Radical Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Head and Neck Tumors


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

29 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are: 1. evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors. 2. the exploration of efficacy-related immune microenvironment genes Participants will receive tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of an immunotherapy drug called tislelizumab with chemotherapy (APF regimen) in people who have locally advanced cancers of the head and neck — including the mouth, throat, voice box, and nearby areas. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with squamous cell carcinoma of the head, neck, or throat (stage III–IVb, or stage II–III if HPV-positive) - You have not received chemotherapy, radiation, or other cancer treatments before - You are generally healthy enough to function independently (ECOG 0–1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have cancer that has spread to distant parts of the body - You have an active autoimmune disease (like lupus, Crohn's, or similar conditions) - You have HIV, uncontrolled hepatitis B or C, or a weakened immune system - You have severe heart problems, active infections, or lung disease - You are pregnant or breastfeeding 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

DRUGTislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU

evaluate the efficacy and safety of immunotherapy combined with chemotherapy


Locations(1)

Department of Oncology, Drum Tower Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, China

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NCT05758389


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