Actively Recruiting
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
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-02-05
104
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 to 75 years old
- Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above
- Undergoing concurrent chemoradiotherapy
- ECOG performance status of 0 to 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion
- Absolute neutrophil count (ANC) > 1.5×10⁹/L, hemoglobin > 8g/dL, and platelet > 100×10⁹/L
- Prothrombin time (PT) <1.5 times the upper limit of normal and normal thromboplastin time (APTT) <1.5 times the upper limit of normal
- Serum creatinine ≤ 1.5 times the upper limit of normal or 24-hour creatinine clearance > 50 ml/min if elevated
- ALT or AST ≤ 2.5 times the upper limit of normal and total bilirubin ≤ 1.5 times the upper limit of normal without liver metastases; with liver metastases, ALT or AST ≤ 5 times and total bilirubin ≤ 3 times the upper limit of normal
- Females of childbearing potential must agree to use adequate contraception during treatment
- Signed informed consent
- At the end of radiotherapy, PD1+CD8T cells in peripheral blood > 10% or more than twice baseline
You will not qualify if you...
- Active autoimmune disease requiring systemic therapy within the past 2 years
- Diagnosed immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days prior to first dose
- Other progressing malignancies requiring active treatment except certain cured skin or cervical cancers
- Active infection requiring systemic therapy
- Medical history or disease that could affect study participation or results
- Known psychiatric or substance abuse disorder affecting compliance
- Pregnant or lactating females, or males with partners planning pregnancy during or shortly after the study
- Known HIV infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang, prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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