Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT05220267
Status:
UNKNOWN
Last Update Posted:
2022-02-02
First Post:
2021-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}, {'id': 'C000632826', 'term': 'sintilimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2021-12-24', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'Time from treatment until disease progression or death'}], 'secondaryOutcomes': [{'measure': 'objective response rate (ORR)', 'timeFrame': 'up to 2 years', 'description': 'objective response rate (ORR) by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR)'}, {'measure': 'disease control rate (DCR)', 'timeFrame': 'up to 2 years', 'description': 'disease control rate (DCR)by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) and Stable Disease(SD).'}, {'measure': 'overall survival (OS)', 'timeFrame': 'up to 2 years', 'description': 'Time from treatment until death from any cause'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Clear Cell Renal Carcinoma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Bray F,Ferlay J,Soerjomatarm I,et al.Global cancer statistics 2018:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J].CA Cancer J Clin,2018,68(6):394-424. 2. Choueiri T,Motzer R.Systemic therapy for metastatic renal-cell carcinoma[J].N Engl J Med,2017,376(4):354-366 3. ESCUDIER B,EISEN T,STADLER W M,et al.Sorafenib in advanced clear cell renal-cell carcinoma[J].N Engl J Med,2007,356(2):125-134 4. MOTZER R J,HUTSON T E,TOMCZAK P,et al.Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma[J].J Clin Oncol,2009,27(22):3584-3590 5. Armstrong AJ, Halabi S, Eisen T, et al. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016;17(3):378-388. 6. Nizar M Tannir, Eric Jonasch, Laurence Albiges, et al. Everolimus Versus Sunitinib Prospective Evaluation in Metastatic Non-Clear Cell Renal Cell Carcinoma (ESPN): A Randomized Multicenter Phase 2 Trial[J]. European Urology, 2016, 69(5):866-874. 7. Motzer RJ, Barrios CH, Kim TM, et al.: Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and secondline everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol 2014; 32:2765-2772. 8. Zhou AP,Bai Y,Song Y,et al. Anlotinib Versus Sunitinib as First-Line Treatment for Metastatic Renal Cell Carcinoma:A Randomized PhaseⅡClinical Trial[J]. Oncologist,2019,24(8):e702-e708. DOI:10.1634/theoncologist.2018-0839. 9. CHOUEIRI T K,FISHMAN M N,ESCUDIER B,et al.Immunomodulatory activity of nivolumab in metastatic renal cell carcinoma[J].Clin Cancer Res,2016,22(22):5461-5471. 10. MCDERMOTT D F,SOSMAN J A,SZNOL M,et al.Atezolizumab,an antiprogrammed death-ligand 1 antibody,in metastatic renal cell carcinoma:long-term safety,clinical activity,and immune correlates from a phase Ⅰa study[J].J Clin Oncol,2016,34(8):833-842. 11. Rini, BI; Plimack, ER; Stus, V; et al.Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.[J].N Engl J Med.2019,380(12):1116-1127 12. YASUDA S,SHO M,YAMATO I,et al.Simultaneous blockade of programmed death 1 and vascular endothelial growth factor receptor 2 (VEGFR2) induces synergistic anti-tumour effect in vivo[J].Clin Exp Immunol,2013,172:500-506'}]}, 'descriptionModule': {'briefSummary': 'The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects voluntarily joined the study and signed informed consent;\n* Aged \\> 18 years;\n* ECOG body status score is 0 or 1,Expected survival time is greater than 3 months.\n* Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.\n* Patients must have measurable lesions as defined by the RECIST 1.1 standard;\n* Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment:\n\n 1. Absolute neutrophil count (ANC) ≥1.5x 109/L\n 2. Lymphocyte count ≥ 500/uL.\n 3. Platelet count ≥ 80x109/L.\n 4. Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion).\n 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver/bone metastases should have AST and ALT ≤ 5 x ULN.\n 6. Serum bilirubin ≤ 1.5 x ULN.\n 7. Creatinine clearance ≥ 60 mL/min.\n 8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use 4 weeks after the last dose of anlotinib or sintilimab.\n* Signed informed consent form.\n* Ability and capacity to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n* Those who are known to be allergic to pharmaceutical ingredients.\n* Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1;\n* Previous use of anlotinib or other angiogenesis inhibitors\n* The patient has any active autoimmune disease or a history of autoimmune disease;\n* There are uncontrolled heart clinical symptoms or diseases;\n* Patients with congenital or acquired immune deficiency;\n* Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment;\n* A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment;\n* Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism;\n* Those with active bleeding or bleeding tendency;\n* Presence of a drug uncontrolled hypertension;\n* Urine routine indicates more than urinary protein 2+;\n* Correct QT interval \\> 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study;\n* Patients suspected of having other primary cancers;\n* Those who are known to be allergic to pharmaceutical ingredients.\n* Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening). Patients with past/resolved HBV infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible. A negative HBA DNA test must be obtained in patients with positive hepatitis B core antibody prior to Cycle 1 Day 1.\n* Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.\n* Pregnant or lactating women."}, 'identificationModule': {'nctId': 'NCT05220267', 'briefTitle': 'Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'SL-B2021-245-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Anlotinib plus Sintilimab', 'description': 'Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle) .Sintilimab was administered intravenously (200mg once every 3weeks).', 'interventionNames': ['Drug: Anlotinib plus Sintilimab']}], 'interventions': [{'name': 'Anlotinib plus Sintilimab', 'type': 'DRUG', 'description': 'Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle).Sintilimab was administered intravenously (200mg once every 3weeks).', 'armGroupLabels': ['Anlotinib plus Sintilimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Fang-Jian Zhou, M.D Ph.D', 'role': 'CONTACT', 'email': 'zhoufj@sysucc.org.cn', 'phone': '+8613922735659'}, {'name': 'Pei Dong, M.D Ph.D', 'role': 'CONTACT', 'email': 'dongpei@sysucc.org.cn', 'phone': '13512738496'}, {'name': 'Fang-Jian Zhou, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pei Dong, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiu-Yu Cai, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'ZHOU FANGJIAN', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}