Actively Recruiting
Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Tumors Using Peripheral Blood CD8Tex Detection
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-02-05
104
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of maintenance therapy with Sintilimab after chemoradiotherapy in patients with locally advanced head and neck squamous cell carcinoma. This prospective, randomized, single-blind controlled clinical study aims to compare Sintilimab to a placebo in this patient population. The study focuses on how well Sintilimab works in preventing disease progression and its safety profile. Participants will start treatment within one month after completing chemoradiotherapy. The experimental group receives Sintilimab intravenously on the first day of each 21-day cycle, while the control group receives a placebo with the same schedule. Up to 18 treatment cycles are planned, or treatment continues until disease progression. Blood tests and electrocardiograms will be repeated every two cycles, and CT scans every four cycles to monitor toxicity, side effects, and cancer recurrence. During the study, participants will undergo regular assessments including laboratory tests, imaging, and quality of life questionnaires. Researchers will track progression-free survival over one and three years as primary outcomes and will also evaluate overall survival, safety, tolerability, and quality of life over three years. The total participation period covers treatment cycles and follow-up evaluations to monitor long-term outcomes.
CONDITIONS
Brief 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 aged 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
- Blood test with absolute neutrophil count > 1.5x10^9/L, hemoglobin > 8g/dL, and platelet > 100x10^9/L
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) less than 1.5 times the upper limit of normal
- Serum creatinine ≤ 1.5 times the upper limit of normal or creatinine clearance > 50ml/min
- Liver enzyme levels within specified limits depending on liver metastases status
- Females of childbearing potential willing to use contraception during treatment
- Signed informed consent
- Peripheral blood PD1+CD8T cells > 10% or more than twice baseline at end of radiotherapy
You will not qualify if you...
- Active autoimmune disease requiring systemic therapy in the past 2 years
- Immunodeficiency or recent immunosuppressive therapy within 7 days before trial
- Other progressing malignancies needing treatment (except certain skin and cervical cancers)
- Active infections requiring systemic therapy
- Medical conditions or lab abnormalities that may interfere with study participation
- Known psychiatric or substance abuse disorders affecting compliance
- Pregnant or lactating females, or those planning pregnancy during or up to 180 days after treatment; males with partners planning pregnancy
- Known HIV infection (HIV 1/2 antibodies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 cycles of 21 days each or until disease progression
Participants receive immune checkpoint maintenance therapy with intravenous Sintilimab or placebo on the first day of each 21-day cycle.
1 visit every 21 days for up to 18 cycles
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.
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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