Ignite Creation Date:
2025-12-17 @ 1:17 PM
Ignite Modification Date:
2025-12-23 @ 4:55 PM
Study NCT ID:
NCT06038461
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2023-09-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'C079198', 'term': 'S 1 (combination)'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Surufatinib Combined With Temozolomide and S-1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-28', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'approximately 1 years', 'description': 'the proportion of patients with complete response or partial response, using RESIST v1.1'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'approximately 1 years', 'description': 'time from first-dose to the first documented disease progression or death'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'approximately 1 years', 'description': 'the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surufatinib', 'Temozolomide and S-1', 'First-line treatment'], 'conditions': ['Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib Combined With Temozolomide and S-1 as the first-line treatment of advanced neuroendocrine tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75years (inclusive);\n* Histopathologically confirmed diagnosis of advanced MGMT0/1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis);\n* Previously untreated with systemic therapy;\n* Have at least one measurable lesion according to RECIST v1.1;\n* ECOG performance status: 0-2(determined by investigator);\n* Expected survival time \\> 3 months;\n* Adequate hepatic, renal, heart, and hematologic functions;\n* Urine protein \\< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;\n* Before the first dose, serum HCG examination of potential childbearing-women must be negative; Men/Women of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion.\n\nExclusion Criteria:\n\n* Neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid,\n* Functional NETs which need to control symptoms by long-acting somatostatin analogues;\n* Received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment;\n* Have uncontrolled hypertension, defined as systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mm Hg, while under anti-hypertension treatment;\n* Patients with active ulcer, intestinal perforation and intestinal obstruction;\n* With active bleeding or bleeding tendency;\n* Severe history of cardiovascular and cerebrovascular diseases;\n* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.'}, 'identificationModule': {'nctId': 'NCT06038461', 'briefTitle': 'An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors', 'orgStudyIdInfo': {'id': 'HMPL-012-SPRING-NEN106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surufatinib Combined With Temozolomide and S-1', 'description': 'Patients will receive surufatinib combined with temozolomide and S-1 once every three weeks as the second-line treatment until disease progression or intolerable toxicity or patients withdrawal of consent.\n\nPhase I: DLTs of surufatinib combined with temozolomide and S-1 will be evaluated based on NCI CTCAE v 5.0 in the first cycle.', 'interventionNames': ['Drug: Surufatinib Combined With Temozolomide and S-1']}], 'interventions': [{'name': 'Surufatinib Combined With Temozolomide and S-1', 'type': 'DRUG', 'description': 'Phase I:\n\nSurufatinib: 250mg, QD, PO, Q3W; Temozolomide: 200-300mg, d10-d14, QD, PO, Q3W; S-1: 40-60mg, d1-d14, BID, PO, Q3W.\n\nPhase II:\n\nSurufatinib, Temozolomide and S-1：RP2D', 'armGroupLabels': ['Surufatinib Combined With Temozolomide and S-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yihebali Chi, doctor', 'role': 'CONTACT'}], 'facility': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yihebali Chi, PhD', 'role': 'CONTACT', 'email': 'yihebalichi@hotmail.com', 'phone': '010-67781331'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Medical Oncology', 'investigatorFullName': 'Yihebali Chi, MD', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}