RecruitingPhase 2NCT06240689

A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood

A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head And Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

104 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this prospective, randomized, single-blind controlled clinical study is to explore the efficacy of maintenance therapy with Sintilimab after chemoradiotherapy in locally advanced head and neck squamous cell carcinoma. The main questions it aims to answer are: How works well the Sintilimab was in the treatment group? How safe the Sintilimab is? Participants will intravenous Sintilimab or placebo (a look-alike substance that contains no active drug) within 1 month after the end of chemoradiotherapy, and 21 days is a cycle. Blood tests, electrocardiogram are rechecked every 2 cycles, and CT was rechecked every 4 cycles to evaluate toxicity and side effects and recurrence. Researchers will compare invention group to control group to see if the Sintilimab works well.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immune checkpoint therapy (a type of immunotherapy) after completing chemoradiation helps people with locally advanced head and neck tumors. Researchers are using a blood test that measures exhausted immune cells (CD8Tex) to identify which patients are most likely to benefit from ongoing immunotherapy after their initial treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with inoperable locally advanced head and neck cancer (stage T3 or higher, or involving lymph nodes) - You are undergoing or have completed concurrent chemoradiotherapy - Your general health status is good (ECOG 0–1) - Your blood counts, kidney, and liver function meet the required levels **You may NOT be eligible if...** - You have not completed chemoradiotherapy - Your organ function does not meet the study requirements - You are pregnant - Your performance status is poor 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

DRUGSintilimab

Sintilimab is administered intravenously on the first day of each cycle. 21 days per cycle.

DRUGPlacebo

Placebo is administered intravenously on the first day of each cycle. 21 days per cycle.


Locations(1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT06240689


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