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SABRE STUDY will explore effectiveness and safety of the combination therapy of camrelizumabļ¼apatinib 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT/LDRT + Camrelizumab +Apatinib | Experimental | SBRTļ¼8GyĆ3fļ¼ LDRTļ¼2GyĆ5fļ¼ Camrelizumabļ¼200mgļ¼q3wļ¼ Apatinib ļ¼250mgļ¼qdļ¼ |
|
| SBRT + docetaxel | Active Comparator | docetaxel 75mg/m2 SBRTļ¼8GyĆ3fļ¼ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab (AiRuiKaā¢), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective Response Rate at 6 months using RECIST1.1 criteria | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Weeks |
| Progression-free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CongHua Xie, MD | Contact | 02767812510 | 86 | chxie_65@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| CongHua Xie, MD | Wuhan University | Principal Investigator |
| You Lu, MD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
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|
| Apatinib | Drug | Apatinib [AitanĀ® (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 injection | Drug | Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug |
|
| SBRT | Radiation | 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. |
|
| LDRT | Radiation | low dose radation therapy |
|
Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)
| 6 Weeks |
| Overall Survival | Time from enrollment until death due to any cause | 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 | From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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