- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240689
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ting Zhang, Prof.
- Phone Number: +8615157125533
- Email: zezht@zju.edu.cn
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- The Second Affiliated Hospital of Zhejiang University
-
Contact:
- Ting Zhang, Prof.
- Phone Number: +8615157125533
- Email: zezht@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion 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 creatinine clearance rate is > 50ml/min).
- 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 the reference range of normal values; for patients with liver metastases, ALT or AST is less than or equal to 5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 3 times of the upper limit of the reference range of normal values.
- 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
Exclusion Criteria:
- 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 physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments.
- 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 of physiologic doses of corticosteroids may be approved.
- 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 therapy are excluded.
- 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 believes that participation in the study is not in the best interest of the subject.
- Known psychiatric or substance abuse disorder that may affect compliance with test requirements.
- Female subjects 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 subjects whose spouse is preparing to become pregnant.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional arm
The experimental group started treatment within 1 month after the end of chemoradiotherapy, and Sintilimab was given intravenously on the first day of each cycle, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression.
|
Sintilimab is administered intravenously on the first day of each cycle.
21 days per cycle.
Other Names:
|
Placebo Comparator: Control arm
The control group started treatment within 1 month after the end of chemoradiotherapy, and placebo was given intravenously on the first day of each cycle, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression.
|
Placebo is administered intravenously on the first day of each cycle.
21 days per cycle.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 3 years
|
progression-free survival
|
3 years
|
1-year PFS
Time Frame: 1 year
|
1-year progression-free survival
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 3 years
|
Overall Survival
|
3 years
|
Safety and tolerability
Time Frame: 3 years
|
All adverse events will be assessed by the investigator in accordance with NCI Common Terminology for Adverse Events (CTCAE) version 5.0.
|
3 years
|
EORTC Quality of Life Questionnaire Head and Neck (H&N)-35 scores
Time Frame: 3 years
|
Assessment of quality of life of HNSCC
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Y2023-0889
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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