[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541444":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":48,"collaborators":30,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":30,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":30,"overallStatus":70,"whyStopped":30,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Surufatinib in combination with Camrelizumab and mFOLFOX6",[13],"Drug: Surufatinib 250mg\u002Fd qd once daily",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Surufatinib 250mg\u002Fd qd once daily","mFOLFOX6( Oxaliplatin + Leucovorin + fluorouracil) Oxaliplatin 85mg\u002Fm2 d1+CF 400mg\u002Fm2 d1+5-FU 400mg\u002Fm2d1 \u002F2400mg\u002Fm2 continuous intravenous injection (civ) for 46h, The drug is administered every 14 days for a total of 8-12 cycles.",[9],[21],"Camrelizumab 200mg,IV,Q2W once every 21 days during the maintenance treatment period, for a maximum of 2 years",[23],{"name":24,"affiliation":5,"role":25},"Rui Hua Xu, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","13922206676",null,"xurh@sysucc.org.cn",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Hui Yan Luo, DR","13719459226","luohy@sysucc.org.cn",[37],{"facility":38,"status":30,"city":39,"state":30,"zip":30,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":30},"SunYat-senUniversity Cancer Center","Guangzhou","China","CN",{"type":43,"coordinates":44},"Point",[45,46],113.25,23.11667,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Rui-hua Xu, MD, PhD","Chief physician","100541444","phase-2-a-phase-ii-study-of-surufatinib-combined-with-camrelizumab-and-mfolfox6-as-second-line-treatment-for-advanced-prad-100541444",false,"NCT06329947","A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD","Inclusion Criteria:\n\n1. Have full understanding of this study and voluntarily sign the informed consent form;\n2. Male and Female aged between 18 and 75 years are eligible;\n3. Histologically or cytologically confirmed metastatic pancreatic cancer;\n4. Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression\u002Frecurrence during previous neoadjuvant\u002Fadjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant\u002Fadjuvant treatment plan Also gemcitabine-based chemotherapy;\n5. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n7. Predicted survival ≥12 weeks;\n8. Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Participated in other anti-tumor drug clinical trials within 28 days;\n2. Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);\n3. Have previously received anti-vascular endothelial growth factor\u002Fvascular endothelial growth factor receptor (VEGF\u002FVEGFR) targeted drug treatment;\n4. Those who are known to be allergic to any of the drugs in the study;\n5. Brain metastasis accompanied by symptoms or symptom control time \\\u003C2 months;\n6. The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ);\n7. Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):\n\n   1. Absolute neutrophil count (ANC) \\\u003C1.5×109\u002FL;\n   2. Platelets \\\u003C100×109\u002FL;\n   3. Hemoglobin \\\u003C8g\u002FdL.\n8. Liver abnormalities:\n\n   1. When there is no liver metastasis, ALT, AST or ALP\\>2.5×the upper limit of the normal reference range (ULN); when there is liver metastasis, ALT, AST or ALP\\>5×ULN;\n   2. Serum total bilirubin \\>1.5×ULN (Gilber syndrome \\>3×ULN);\n   3. Decompensated cirrhosis (Child-Pugh liver function grade B or C);\n   4. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000IU\u002FmL (those who are HBsAg positive and hepatitis B virus DNA copy number \\\u003C2000IU\u002FmL need to receive at least 2 weeks of anti-HBV treatment before taking the first dose) ;\n   5. Hepatitis C virus (HCV) antibody positive and HCVRNA test positive.\n9. Kidney abnormalities:\n\n   1. Serum creatinine\\>1.5×ULN;\n   2. Routine urine test shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be \\>1.0g;\n   3. Renal failure requiring hemodialysis or peritoneal dialysis;\n   4. Past history of nephrotic syndrome.；","ALL","18 Years","75 Years",{"count":62,"type":63},37,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer",[69],"Advanced Pancreatic Cancer","NOT_YET_RECRUITING","2024-05-06",{"date":73,"type":74},"2024-05-08","ACTUAL",{"date":76,"type":63},"2024-05-22",{"date":78,"type":63},"2026-09-30",{"name":50,"class":6},1]