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New treatment option for Locally Advanced Head and Neck Squamous Cell Carcinoma
Official title 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
ClinicalTrials.gov ID: NCT06240689
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced head and neck squamous cell carcinoma.
Also referred to as IBI308.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female, age ≥ 18 years old, ≤ 75 years old.
- Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above.
- Patients undergoing concurrent chemoradiotherapy
- ECOG performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
You likely can't join if
- Active autoimmune disease requiring systemic therapy (i.e., use of disease-modifying medications, corticosteroids, or immunosuppressants) within the...
- Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first...
- Other malignancies that are known to be progressing or requiring active treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the...
- Have an active infection requiring systemic therapy.
- Medical history or evidence of disease that may confound the results of the trial, prevent the subject from participating in the study throughout the...
- Known psychiatric or substance abuse disorder that may affect compliance with test requirements.
See the full eligibility criteria
- Male or female, age ≥ 18 years old, ≤ 75 years old.
- Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above.
- Patients undergoing concurrent chemoradiotherapy
- ECOG performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
- At least one measurable lesion
- Blood test: absolute neutrophil count (ANC) \> 1.5×109/L, hemoglobin \> 8g/dL and platelet \> 100 ×109/L (subject to the normal value of the clinical trial center).
- Prothrombin time (PT) \<1.5 times the upper limit of normal and normal thromboplastin time (APTT) \<1.5 times the upper limit of normal.
- Laboratory examination, serum creatinine less than or equal to 1.5 times the upper limit of the reference range of normal values (If serum creatinine is elevated, 24-hour urine must be collected. Except for the 24-hour...
- In the absence of liver metastases, ALT or AST is less than or equal to 2.5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 1.5 times the upper limit of...
- Females of childbearing potential must be willing to use adequate contraception for the duration of study drug treatment.
- Signed informed consent.
- At the end of radiotherapy, the proportion of PD1+CD8T cells in peripheral blood is greater than 10%, or more than 2 times higher than baseline
- Active autoimmune disease requiring systemic therapy (i.e., use of disease-modifying medications, corticosteroids, or immunosuppressants) within the previous 2 years. Replacement therapies (e.g., thyroxine, insulin, or...
- Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial therapy. After consultation with the sponsor, the use...
- Other malignancies that are known to be progressing or requiring active treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has received curative...
- Have an active infection requiring systemic therapy.
- Medical history or evidence of disease that may confound the results of the trial, prevent the subject from participating in the study throughout the study, abnormal treatment or laboratory values, or the investigator...
- Known psychiatric or substance abuse disorder that may affect compliance with test requirements.
- Female people who are pregnant or lactating, or who are expected to conceive during the planned trial period or up to 180 days after the last dose of study treatment, or male people whose spouse is preparing to become...
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) infection.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.