[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386976":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":28,"responsibleParty":45,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":11,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"West China Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL",null,[13],"Drug: Camrelizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Camrelizumab","Camrelizumab was administered 200mg iv every 3 weeks, Apatinib was administered 250 mg p.o. qd.",[9],[21],"Apatinib",[23],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Xingchen Peng","CONTACT","+86 18980606753","pxx2014@scu.edu.cn",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"West China Hospital, Sichuan University","RECRUITING","Chengdu","Sichuan","610041","China","CN",{"type":38,"coordinates":39},"Point",[40,41],104.06667,30.66667,{"lat":41,"lon":40},[44],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},{"type":46,"investigatorFullName":24,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","PhD, Associate Professor","100386976","phase-2-phase-ii-study-for-combination-of-camrelizumab-and-apatinib-in-the-second-line-treatment-of-recurrent-or-metastatic-adrenocortical-carcinoma-100386976",false,"NCT04318730","Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of adrenocortical carcinoma;\n2. Patients with metastatic or inoperable adrenocortical carcinoma that has progressed, metastasized, or recurred after first-line standard treatment (mitotane monotherapy, chemotherapy alone, mitotane combined chemotherapy);\n3. Aged \\>=18 years;\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n5. At least one measurable lesion, according to RECIST 1.1;\n6. Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion): HB≥80g\u002FL, ANC≥1.5x10\\^9\u002FL, PLT ≥80x10\\^9\u002FL; TBIL≤1.5 ULN, ALT and AST ≤2.5 ULN, if there exists hepatic metastases, ALT and AST ≤5 ULN, Cr ≤1.5 ULN or CCr ≥60ml\u002Fmin; INR or PT ≤1.5 ULN, APTT ≤1.5 ULN (if the patient is receiving anticoagulant therapy, PT and APTT should be within the expected treatment range); Cardiac Markers and BNP≤ULN；TSH≤ULN (If TSH is abnormal, T3 and T4 should be normal)\n7. Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment;\n8. Have signed consent form.\n\nExclusion Criteria:\n\n1. Patients with another primary malignancy within 5 years prior to starting the study drug, except for cured in situ cervical carcinoma and cured non-melanoma skin cancer;\n2. Have central nervous system metastasis with symptoms and need hormonal intervention;\n3. Had received strong CYP3A4 inhibitors within one week prior to enrollment or received strong CYP3A4 inducers within two weeks prior to enrollment;\n4. Poor control of high blood pressure (SBP\\>140mmHg or DBP\\>90mmHg);\n5. Congestive heart failure of New York Heart Association (NYHA) Class III or IV;\n6. Thromboembolic events occurred within 1 year prior to enrollment;\n7. ECG QT interval \\>500ms;\n8. Previous systemic immunosuppressive therapy;\n9. Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment;\n10. Received TKI treatment within 2 weeks prior to starting the study drug;\n11. Participate in clinical trials of other interventional drugs within 4 weeks prior to starting the study drug;\n12. Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug;\n13. An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the study drug;\n14. Major surgery or severe trauma within 4 weeks prior to starting the study drug;\n15. Severe infections occurred within 4 weeks prior to starting the study drug;\n16. Have an active autoimmune disease or a history of autoimmune diseases;\n17. Have a history of immunodeficiency;\n18. Have an active tuberculosis infection;\n19. Have active hepatitis;\n20. Patients with symptoms of gastrointestinal bleeding or risk of bleeding;\n21. Active infection, or patients are pregnant or breast-feeding.","ALL","18 Years",{"count":57,"type":58},21,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","Adrenocortical carcinoma (ACC) is a rare aggressive malignant tumor. According to the literature, the 5-year survival rate of ACC is 12%-47%. For patients with advanced ACC, mitotane alone or combined with traditional chemotherapy was the first-line standard treatment, but its progression-free survival was only about 1 year. However, for patients who fail the first-line treatment, there is a lack of effective treatment. For ACC patients who had failed first-line chemotherapy, a phase II clinical trial found that the objective response rate and the disease control rate of PD-1 inhibitor Keytruda were 14% and 64% respectively, and no grade 3 or 4 adverse events were observed. Anti-tumor angiogenic drugs combined with PD-1 inhibitors have shown impressive clinical data in many solid tumors. This study is aimed to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined with apatinib in patients with recurrent or metastatic ACC after standard treatment failure, and to seek new treatment for this population.",[64],"Adrenocortical Carcinoma","2024-07-16",{"date":67,"type":68},"2024-07-17","ACTUAL",{"date":70,"type":68},"2020-10-01",{"date":72,"type":58},"2025-04-01",{"name":5,"class":6},1]