Phase
Condition
Cancer Treatment
Neoplasm Metastasis
Cancer
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18-80 years old;
Spine metastatic tumor patients confirmed by pathology and imaging; Number 3; Surgicaltreatment is not possible due to iatrogenic or (and) personal factors;
Spinal metastasis after previous systemic treatment or progression after previoustreatment of spinal metastasis;
The anatomy of the spinal metastases form Tomita parting Ⅰ type - Ⅲ type; Withoutsystemic metastasis or metastasis, the lesion was controlled.
ECOG physical condition score: 0-1, Karnofsky score 60, able to withstand puncture;
Expected survival 3 months;
Main organ function is good, without serious hypertension, diabetes and heart disease.
Has signed informed consent;
The compliance was good and the family members agreed to follow up for survival.
Exclusion
Exclusion Criteria:
Of the anatomy of the spinal metastases form Tomita classification: Ⅳ, Ⅴ Ⅵ, Ⅶ.
Participated in other drug clinical trials within four weeks; There was a history ofbleeding, and any bleeding event with severe grade of CTCAE5.0 or above occurredwithin 4 weeks before screening;
Screening of patients with known central nervous system metastasis or a history ofcentral nervous system metastasis. For patients with clinical suspected centralnervous system metastasis, CT or MRI examination must be performed within 14 daysbefore randomization to exclude central nervous system metastasis.
Patients with hypertension who cannot obtain good control by single antihypertensivedrug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);Having a history of unstable angina pectoris; Patients newly diagnosed with anginawithin 3 months before screening or myocardial infarction within 6 months beforescreening; Arrhythmia (including QTcF: 450ms in male and 470ms in female) requireslong-term use of anti-arrhythmia drugs and New York heart association grade II cardiacdysfunction;
Long-term unhealed wounds or incomplete fracture healing;
Imaging showed that the tumor had invaded important blood vessels or the researchersjudged that the patient's tumor had a very high possibility to invade important bloodvessels during the treatment and cause fatal bleeding;
Coagulation function is unusual, have haemorrhage tendency person (before random 14days must satisfy: below the circumstance that does not use anticoagulant INR is innormal value range); Patients treated with anticoagulants or vitamin K antagonistssuch as warfarin, heparin or their analogues; The use of low-dose warfarin (1mg oral,once daily) or low-dose aspirin (no more than 100mg daily) for preventive purposes ispermitted on the premise that the international standardized ratio of prothrombin time (INR) is 1.5;
Screening for the occurrence of hyperactive/venous thrombosis events in the first 6months, such as cerebrovascular accidents (including temporary ischemic attack), deepvein thrombosis (except for venous thrombosis caused by intravenous catheterization inthe early stage of chemotherapy, which was determined by the researchers to haverecovered) and pulmonary embolism, etc.
Thyroid function was abnormal in the past and could not be kept within the normalrange even in the case of drug treatment.
(10) Attending has a history of psychotropic drug abuse, and can't attend or hasmental disorder;
Always half a year after spinal tumors or other close to the spine tumor lesionlesions radiation;
Immunodeficiency disease, or has other acquired, congenital immunodeficiency disease,or has a history of organ transplantation;
Judgment according to the researchers, there is serious to endanger the safety ofpatients or patients completed the research associated with disease.
Study Design
Study Description
Connect with a study center
The fifth medical center of PLA general hospital
BeiJing, Beijing 100000
ChinaActive - Recruiting
Peking University Third Hospital
Beijing, Beijing 100000
ChinaActive - Recruiting
Guangxi ruikang hospital
NanNing, Guangxi 530000
ChinaActive - Recruiting
Third Affiliated Hospital of Guizhou Medical University
GuiYang, Guizhou 550000
ChinaActive - Recruiting
GEM flower hospital of Liaohe oil field Tang-Du Hospital
Panjin, Liaoning 124010
ChinaActive - Recruiting
Hiser Medical Center of Qingdao
Qingdao, Shandong 266000
ChinaActive - Recruiting
Qingdao chengyang people's hospital
Qingdao, Shandong 266000
ChinaActive - Recruiting
Second hospital of Shanxi Medical University
TaiYuan, Shanxi 030000
ChinaActive - Recruiting
Tangdu hospital
Xian, Shanxi 710000
ChinaActive - Recruiting
Mianyang Central Hospital
Mianyang, Sichuan 621000
ChinaActive - Recruiting

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