Actively Recruiting
Radiotherapy With Tislelizumab in Patients With Recurrent Head & Neck Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2022-10-27
20
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the efficacy and safety of pulsed radiotherapy given concomitantly with Tislelizumab and as maintenance therapy in participants with locoregionally recurrent head and neck squamous cell carcinoma ( HNSCC).
CONDITIONS
Official Title
Radiotherapy With Tislelizumab in Patients With Recurrent Head & Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of squamous cell head and neck cancer with Karnofsky performance status 70 or higher
- Previous radical therapy including surgery with or without chemoradiotherapy or radical chemoradiotherapy, with available records of radiation fields and dosage
- Tumor is inoperable or completely resectable after multidisciplinary team consultation
- Measurable or non-measurable tumor lesions assessed by CT or MRI based on RECIST version 1.1
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first treatment
- Female and male participants of reproductive potential must agree to use effective contraception during the study and for 180 days after last dose
You will not qualify if you...
- Pregnant or breastfeeding, or planning pregnancy during the study
- History of another malignant tumor except head and neck squamous cell carcinoma
- Active autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, HIV positive, or history of organ transplantation
- Received re-radiotherapy within 1 month before entering the study
- Receiving or expecting to receive systemic immunosuppressive drugs within 2 weeks before or during study treatment
- Received systemic immune-stimulating agents like interferon or interleukin-2 within 4 weeks before study treatment
- History of other malignancies within past 5 years except cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ
- Severe cardiovascular disease such as New York College of Cardiology heart disease class II or greater, recent myocardial infarction, unstable arrhythmia, or unstable angina within 3 months before study
- Active infection or fever over 38.5°C during screening or before first dose
- Received therapeutic oral or intravenous antibiotics within 2 weeks before study; prophylactic antibiotics allowed
- Untreated active hepatitis B or C requiring antiviral therapy during study
- Immunotherapy such as PD-1/L1 or CTLA-4 antibodies within 4 weeks before enrollment
- Chemotherapy or targeted therapy within 4 weeks prior to enrollment
- Participation in other clinical trials within 4 weeks prior to enrollment
- Need for other antitumor treatments or vaccination during study or within 4 weeks prior
- Other comorbidities judged by investigator to seriously risk safety or study completion
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sichuan Cancer Hosiptal
Chengdu, Sichuan, China
Actively Recruiting
2
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
X
Ximei Zhang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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