Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
Study NCT ID:
NCT07279532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717729', 'term': 'surufatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarkers', 'timeFrame': '4 years', 'description': 'Concentrations of NSE and ProGRP in blood samples, evaluated as percentage changes at each tumor assessment from baseline to treatment'}], 'primaryOutcomes': [{'measure': 'Recurrence Free Survival（RFS）', 'timeFrame': '4 years', 'description': 'Refers to the time from when a patient achieves complete response after anticancer therapy or surgery until the occurrence of disease recurrence or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival （OS）', 'timeFrame': '4 years', 'description': 'Refers to the time from the start of randomization (or the start of treatment in a single-arm trial) until death due to any cause.'}, {'measure': 'Adverse Event (AE)', 'timeFrame': '4 years', 'description': 'In a drug clinical trial, it refers to all adverse medical events that occur in subjects after receiving the investigational medicinal product, which can manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Neoplasms (Tumours)']}, 'descriptionModule': {'briefSummary': 'The following issues warrant in-depth investigation: further refinement of staging by primary tumor site, the increasing prognostic weight of T classification, risk assessment for lymph node metastasis and postoperative recurrence/distant metastasis, and whether NET G3 with poor prognosis requires more aggressive postoperative intervention. This study plans to enroll patients classified as Stage III according to the AJCC 9th Edition staging system, including NET G1/G2 and all G3 patients, for a clinical trial on postoperative adjuvant therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide written informed consent and voluntarily participate in the study.\n2. Aged 18-80 years, male or female.\n3. Confirmed as Stage III NET G1/G2 or any-stage NET G3 after surgical treatment.\n4. Other postoperative NET patients deemed by the investigator to have high-risk factors.\n5. Adequate organ function meeting the following criteria (no use of any blood components, cell growth factors, or corrective drugs within 14 days prior to the first dose of the study drug): (i) Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; (ii) Platelets ≥100×10⁹/L; (iii) Hemoglobin ≥8 g/dL; (iv) Total Bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (or ≤5 × ULN if liver metastases are present); (v) Serum Creatinine ≤1.5 × ULN or Creatinine Clearance \\>60 mL/min (Cockcroft-Gault formula).\n6. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first study drug dose and use effective contraception during the study and for at least 3 months after the last dose. Male subjects with female partners of childbearing potential must use effective contraception during the study and for 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Major surgery, open biopsy, or significant trauma within 28 days prior to the first dose.\n2. History of severe or poorly controlled interstitial lung disease.\n3. Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite antihypertensive medication.\n4. Poorly controlled cardiovascular diseases, including but not limited to:\n\n (i)NYHA Class II or higher heart failure; (ii) Unstable angina; (iii) Myocardial infarction within the past year; (iv) Clinically significant supraventricular or ventricular arrhythmias poorly controlled with or without intervention.\n5. Significant bleeding tendency or clinically significant bleeding within 3 months prior to the first dose (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis).\n6. Arterial/venous thrombotic events within 6 months prior to the first dose (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism). Superficial vein thrombosis may be enrolled if deemed eligible by the investigator.\n7. Concurrent active malignancy requiring treatment, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.\n8. Pregnancy or lactation.\n9. Any other condition deemed by the investigator to potentially lead to study discontinuation (e.g., severe comorbid illnesses, abnormal laboratory values, psychosocial issues).'}, 'identificationModule': {'nctId': 'NCT07279532', 'briefTitle': 'Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System', 'orgStudyIdInfo': {'id': '2025-1173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Surufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy.', 'interventionNames': ['Drug: surufatinib']}], 'interventions': [{'name': 'surufatinib', 'type': 'DRUG', 'description': 'Surufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy.', 'armGroupLabels': ['Experimental Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}