RecruitingPhase 2NCT05964101

Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma

Neoadjuvant Anti-PD-1 Drug Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma


Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

25 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of the immunotherapy drug nivolumab (which helps the immune system fight cancer) with chemotherapy for people with primary tracheal squamous cell carcinoma — a rare cancer of the windpipe — that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with tracheal squamous cell carcinoma confirmed by biopsy - Scans confirm the cancer has not spread to distant parts of the body - Your physical condition is good (ECOG 0–1) - The tumor has been assessed as early or locally advanced and treatable with intent to cure **You may NOT be eligible if...** - Your cancer has spread beyond the chest to distant organs - You have serious autoimmune conditions that could be worsened by immunotherapy - You have already received chemotherapy or radiation for this cancer - Your organ function (heart, lungs, kidneys, liver) is not adequate for treatment 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

DRUGNivolumab Injection [Opdivo]

Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel


Locations(1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT05964101


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