SABRE STUDY will explore effectiveness and safety of the combination therapy of camrelizumab,apatinib and SBRT/LDRT in patients with metastatic non-small Cell Lung Cancer (NSCLC) patient previously treated With PD-1/L1 Inhibitor and Chemotherapy.
SABRE STUDY consists of two stages. first stage of this trial is a single-arm study that requires enrolling at least 18 patients, all of whom would receive the treatment of SBRT/LDRT in combination with apatinib plus camrelizumab.The trial would proceed into the second stage if 4 or more patients achieve CR/PR. Otherwise, the trial is stopped early due to futility as we fail to reject the null. In the second stage, at least 70 patients are equally randomized into two arms to receive "SBRT/LDRT in combination with apatinib plus camrelizumab" or "SBRT + docetaxel" . Stratified-area group randomization would be used.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd
Apatinib \[Aitan® (brand name in China)\], also known as rivoceranib, is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor
Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGObjective response rate
Objective Response Rate at 6 months using RECIST1.1 criteria
Time frame: 6 Weeks
Duration Response Rate
ime from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause.
Time frame: 6 Weeks
Progression-free Survival
Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)
Time frame: 6 Weeks
Overall Survival
Time from enrollment until death due to any cause
Time frame: 6 Weeks
incidence, type and severity of adverse events
Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Time frame: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)
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Stereotactic body radiation therapy (SBRT) is a cancer treatment that delivers extremely precise, very intense doses of radiation to cancer cells while minimizing damage to healthy tissue. SBRT involves the use of sophisticated image guidance that pinpoints the exact three-dimensional location of a tumor so that the radiation can be more precisely delivered to cancer cells.
low dose radation therapy