Phase
Condition
Digestive System Neoplasms
Cancer
Cancer Treatment
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: 18-80 years old;
Pathologically diagnosed pancreatic cancer patients;Follow-up treatment is inaccordance with the NCCN2019 guidelines for standard treatment.
Clinical MDT discussion, for the unresectable locally advanced pancreatic cancer, AJCCversion 8 pancreatic cancer stage T4N0M0 Arterial invasion: The pancreatic head and neck tumor invasion of pancreas superior mesenteric artery exceed 180 °;More than 180 ° celiac tumor invasion;The tumor invaded the first jejunal branch ofthe superior mesenteric artery.The pancreatic body tail superior mesenteric artery orceliac tumor invasion more than 180 °;The tumor invaded the abdominal trunk and abdominalaorta. Venous invasion: Tumor invasion or embolization (tumor thrombus or thrombus) of the head and neck of thepancreas leads to unresectable superior mesenteric vein or portal vein reconstruction;Thetumor invaded the proximal end jejunal drainage branch of most superior mesentericveins.The invasion or embolization of a tumor in the tail of the pancreas (thrombus orthrombus) leads to the unresectable reconstruction of the superior mesenteric vein orportal vein.
ECOG physical condition score: 0-1, Karnofsky score 60, able to withstand puncture;
Expected survival 3 months;
Good function of main organs, no severe hypertension, diabetes and heart disease.
Signed informed consent;
Has a good compliance, families agree to accept the survival follow-up.
Exclusion
Exclusion Criteria:
Non-locally advanced pancreatic cancer.
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.
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 withangina within 3 months before screening or myocardial infarction within 6 monthsbefore screening;Arrhythmia (including QTcF: 450ms in male and 470ms in female)requires long-term use of anti-arrhythmia drugs and New York heart association gradeII cardiac dysfunction;
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 abnormalities, have bleeding tendency;Patients treated withanticoagulants or vitamin K antagonists such as warfarin, heparin or theiranalogues;The use of low-dose warfarin (1mg oral, once daily) or low-dose aspirin (nomore than 100mg daily) for preventive purposes is permitted on the premise that theinternational 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.
Attending has a history of psychotropic drug abuse, and can't attend or has mentaldisorder;
Always half a year after abdominal tumor lesion 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
Peking University Third Hospital
Beijing, Beijing 100000
ChinaActive - Recruiting
The fifth medical center of PLA general hospital
Beijing, Beijing 100000
ChinaActive - Recruiting
Guangxi Ruikang Hospital
Nanning, Guangxi 530000
ChinaActive - Recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong 277599
ChinaActive - Recruiting

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