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.
- Conditions
- Neoplasms
- Registration Number
- KCT0005512
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 43
1.Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
2.Age= 20 years at time of study entry
3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4.Life expectancy of = 16weeks
5.Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer
6.Unresectable or recurrent
7.Failed to 1st-line chemotherapy for their advanced BTC, but no more than 2 lines of prior chemotherapy regimen
8.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 1.1.
9.Body weight >30kg
10.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
11.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
12.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
13.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
1.Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment, defined as follows:
a.= Grade 3 AE related to anti-PD-1/PD-L1 treatment that did not respond to standard therapy and warranted treatment discontinuation.
b.= 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.
c.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.
2.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:
a.Brain imaging at screening shows no evidence of interim progression
b.All brain metastases with supratentorial location
c.No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
d.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.
e.Following treatment, these patients may then be eligible, provided all other criteria, including those for patients with a history of brain metastases, are met.
3.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:
f.Controlled Type I diabetes
g.Hypothyroidism (provided it is managed with hormone replacement therapy only)
h.Controlled celiac disease
i.Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
j.Any other disease that is not expected to recur in the absence of external triggering factors
4.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)
5.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:
a.Adrenal replacement steroid (dose = 10 mg daily of prednisone or equivalent)
b.Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
c.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)
6.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
7.History of int
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease control rate
- Secondary Outcome Measures
Name Time Method overall response rate;progression-free survival;duration of response;overall survival;toxicity;immune-related adverse event