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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + Pulse radiation | Experimental | Participants receive pulsed radiationtherapy concurrent with 3 cycles of Tislelizumab followed by an additional 32 cycles of Tislelizumab alone as maintenance therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Administered as an intravenous (IV) infusion 200mg every 3 weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) using iRECIST 1.1 criteria | ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with RT, referred to as "Target lesion (RT+ Tisle), as well as the lesion(s) not treated with RT (if applicable), referred to as "Target lesion (Tisle only)", per the prescribed treatment. | From time of first dose of study treatment until disease progression or death (up to 2 years) |
| Adverse Events (AEs) | Number of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. | From time of first dose of study treatment until the end of follow-up (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. | From time of first dose of study treatment until disease progression or death (up to 2 years) |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ximei Zhang, Dr. | Contact | +86-22-23340123 | xiangrikuigirl@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ximei Zhang, Dr. | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hosiptal | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| Pulse radiation | Radiation | 66-70Gy/33-35Fx, 2Gy/Fx. |
|
PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause. |
| From time of first dose of study treatment until disease progression or death (up to 2 years) |
| Change From Baseline Quality of Life (GHS/QoL) | Change from baseline in QoL using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H&N35) | From time of first dose of study treatment until disease progression or death (up to 2 years) |
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|