Phase II Trial of Pulsed Radiotherapy Combined With Tislelizumab in Patients With Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR) using iRECIST 1.1 criteria
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed squamous cell head and neck cancer, A karnofsky performance status≥
- •Previous radical therapy (surgery ± chemoradiotherapy or radical chemoradiotherapy) and the records of radiation fields and dosage of previous treatment can be obtained.
- •Inoperable or completely resectable under MDT consultation.
- •Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
- •Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
- •Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy
排除标准
- •Pregnant or breastfeeding, or planning to become pregnant during the study period
- •The patient had another malignant tumor expcet HNSCC
- •Have an active autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, test positive for HIV or have a history of any of these diseases, or have a history of organ transplantation;
- •They had received reradiotherapy within 1 month prior to entering the study
- •Receiving systemic immunosuppressive drugs within 2 weeks prior to commencing study treatment, or anticipating needing systemic immunosuppressive drugs during study treatment;
- •having received systemic immune-stimulating agents (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks prior to study treatment initiation or remaining within 5 half-lives (whichever is longer);
- •A history of other malignancies within the past 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ;
- •Severe cardiovascular disease (e.g., New York College of Cardiology heart disease class Ⅱ or greater, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months before commences study treatment;
- •The subject has an active infection or infectious disease, or develops a fever of unknown origin (body temperature >38.5 ° C) during screening and before the first dose;
- •had received therapeutic oral or intravenous antibiotics within 2 weeks prior to starting the study; Patients receiving prophylactic antibiotic therapy, such as prevention of urinary tract infection or chronic obstructive pulmonary disease, were enrolled.
- •Untreated active hepatitis (hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA≥104ml; Hepatitis C: HCV-RNA≥103/ml or antiviral therapy required during the study);
- •Immunotherapy such as PD-1/L1 antibody or CTLA-4 antibody within 4 weeks before enrollment.
- •Chemotherapy or targeted therapy within 4 weeks prior to enrollment;
- •Subjects have participated in or completed other clinical trials within 4 weeks prior to enrollment;
- •Subjects may need to receive other antitumor treatments during the study;
- •Subjects may need to have been vaccinated during the study or within 4 weeks prior to enrollment.
- •A patient who, in the investigator's judgment, has other comorbidities that seriously jeopardize the patient's safety or interfere with the patient's completion of the study.
研究组 & 干预措施
Tislelizumab + Pulse radiation
Participants receive pulsed radiationtherapy concurrent with 3 cycles of Tislelizumab followed by an additional 32 cycles of Tislelizumab alone as maintenance therapy.
干预措施: Tislelizumab (Drug)
Tislelizumab + Pulse radiation
Participants receive pulsed radiationtherapy concurrent with 3 cycles of Tislelizumab followed by an additional 32 cycles of Tislelizumab alone as maintenance therapy.
干预措施: Pulse radiation (Radiation)
结局指标
主要结局
Objective response rate (ORR) using iRECIST 1.1 criteria
时间窗: From time of first dose of study treatment until disease progression or death (up to 2 years)
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.
Adverse Events (AEs)
时间窗: From time of first dose of study treatment until the end of follow-up (up to 2 years)
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.
次要结局
- Duration of Response (DOR)(From time of first dose of study treatment until disease progression or death (up to 2 years))
- Progression Free Survival (PFS)(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)(From time of first dose of study treatment until disease progression or death (up to 2 years))