NCT04727996进行中（未招募）2 期
Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer Who Have Failed to At Least 1 Prior Systemic Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Disease control rate
研究概览
简要总结
This is open-label, phase II study enrolling advanced BTC patients who have failed to 1st-line chemotherapy.
详细描述
<Study Objectives>
Primary Objectives:
To characterize the efficacy of Sitravatinib and Tislelizumab combination in biliary tract cancer patients who have failed to 1st-line chemotherapy but no more than 2 lines of prior chemotherapy regimen
Secondary Objectives:
To see the safety of Sitravatinib and Tislelizumab combination in biliary tract cancer patients who have failed to 1st-line chemotherapy
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •Age≥ 20 years at time of study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of ≥ 16weeks
- •Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer
- •Unresectable or recurrent
- •Failed to 1st-line chemotherapy for their advanced BTC, but no more than 2 lines of prior chemotherapy regimen
- •At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging [MRI] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.
- •Body weight >30kg
- •Adequate normal organ and marrow function measured within 28 days prior to administration of study treatment as defined below:
- •Haemoglobin ≥9.0 g/dL
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L
- •Platelet count ≥ 75 x 10 9/L
- •Serum creatinine ≤ 1.5 x upper limit of normal (ULN), or estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation
- •AST and ALT ≤ 3.0 x ULN, or AST and ALT ≤ 5.0 x ULN for patients with documented liver metastases
- •Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome)
- •International normalized ratio (INR) ≤ 1.5 or prothrombin time ≤ 1.5 x ULN
- •Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
- •Patients with inactive/asymptomatic carrier, chronic, or active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at Screening
- •Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drugs and have a negative serum pregnancy test ≤ 7 days of first dose of study drugs
- •Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drugs
排除标准
- •Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment, defined as follows:
- •≥ Grade 3 AE related to anti-PD-1/PD-L1 treatment that did not respond to standard therapy and warranted treatment discontinuation.
- •≥ Grade 2 irAE(immune-related adverse event) associated with anti-PD-1/PD-L1 unless the AE(adverse event) resolved or was well controlled by withholding the anti-PD-1/PD-L1 and/or treatment with steroids, with the exception of prior colitis, encephalitis, myocarditis, hepatitis, uveitis and pneumonitis, which are exclusionary.
- •Central nervous system or ocular AE of any grade related to anti-PD-1/PD-L1 Note: Patients with a prior endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- •Patients with a history of treated and, at the time of screening, asymptomatic CNS metastases are eligible, provided they meet all the following:
- •Brain imaging at screening shows no evidence of interim progression
- •All brain metastases with supratentorial location
- •No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
- •No stereotactic radiation or whole-brain radiation within 14 days prior to first dose of study drug(s)
- •Patients with new asymptomatic central nervous system metastases detected at the screening scan must receive radiation therapy and/or surgery for central nervous system metastases.
- •Following treatment, these patients may then be eligible, provided all other criteria, including those for patients with a history of brain metastases, are met.
- •Active autoimmune diseases or history of autoimmune diseases that may relapse
- •Note: Patients with the following diseases are not excluded and may proceed to further screening:
- •Controlled Type I diabetes
- •Hypothyroidism (provided it is managed with hormone replacement therapy only)
- •Controlled celiac disease
- •Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
- •Any other disease that is not expected to recur in the absence of external triggering factors
- •Any active malignancy ≤ 2 years before first dose of study drugs except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
- •Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drugs
- •Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
- •Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
- •Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
- •Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
- •Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before first dose of study drugs
- •History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung diseases, etc.
- •Severe chronic or active infections (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy, within 14 days prior to first dose of study drugs
- •Known history of HIV infection
- •Active hepatitis C infection (defined by a detectable HCV RNA).
- •Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drugs
- •Prior allogeneic stem cell transplantation or organ transplantation
- •Any of the following cardiovascular risk criteria:
- •Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drugs
- •Symptomatic pulmonary embolism ≤ 28 days before first dose of study drugs
- •Any history of acute myocardial infarction ≤ 6 months before first dose of study drugs
- •Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drugs
- •Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drugs
- •Any history of cerebrovascular accident ≤ 6 months before first dose of study drugs
- •QTc interval (corrected by Fridericia's method) > 450 msec Note: If QTc interval is > 450 msec on initial electrocardiogram (ECG), a follow up ECG will be performed to confirm result
- •Cardiac left ventricular ejection fraction ≤ 40% or lower limit of normal as assessed by echocardiography. The same modality used at baseline must be applied for subsequent evaluations.
- •Any episode of syncope or seizure ≤ 28 days before first dose of study drugs
- •Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
- •Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation, or to any component of the container
- •Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic INR monitoring within 6 months before first dose of study drugs
- •Any systemic chemotherapy within 28 days of the first dose of study drugs or immunotherapy (eg, interleukin, interferon, thymoxin, etc.), hormone therapy, targeted therapy, or any investigational therapies within 14 days or 5 half-lives (whichever is shorter) of first dose of study drugs
- •Any herbal medicine used to control cancer within 14 days of first dose of study drugs
- •Toxicities (as a result of prior anticancer therapy) that have not improved to baseline or stabilized, except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)
- •Administration of live vaccine ≤ 4 weeks prior to first dose of study drugs Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
- •Underlying medical conditions or alcohol or drug abuse or dependence that will be unfavorable for the administration of study drugs or affect the explanation of drug toxicity or AEs; or expected insufficient compliance during the study according to investigator's judgement
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研究组 & 干预措施
Sitravatinib/Tislelizumab
Experimental
All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Sitravatinib (Drug)
Sitravatinib/Tislelizumab
Experimental
All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Disease control rate
时间窗: every 6weeks
To assess the efficacy of Sitravatinib and Tislelizumab combination on DCR (disease control rate) in biliary tract cancer patients who have failed to 1st-line chemotherapy
次要结局
- overall response rate(every 6weeks)
- progression-free survival(every 6weeks)
- overall survival(every 3months)
研究者
Do-Youn Oh
Professor
Seoul National University Hospital
研究点 (1)
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