Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05490667
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Anlotinib Combined With Chemotherapy in the Treatment of Unresectable Advanced Desmoid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018222', 'term': 'Desmoid Tumors'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Up to approximately 24months', 'description': 'From initiation of treatment to tumor progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Desmoid']}, 'descriptionModule': {'briefSummary': 'Thirty patients with desmoid tumors (invasive fibromatosis) will be recruited in the Department of Bone and Soft Tissue, Henan Cancer Hospital. This is a prospective, multicenter, single-arm clinical study to evaluate the efficacy and safety of anlotinib combined with chemotherapy in the treatment of inoperable advanced desmoid tumors.', 'detailedDescription': 'Thirty patients with desmoid tumor (invasive fibromatosis) will be recruited in the Department of Bone and Soft Tissue, Henan Cancer Hospital. This is a prospective, multicenter, single-arm clinical study to evaluate the efficacy and safety of anlotinib combined with chemotherapy in the treatment of inoperative advanced desmoid tumor. To evaluate the 6-month progression-free survival rate, 12-month progression-free survival rate, progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and safety of anlotinib combined with chemotherapy for desmoid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAdvanced desmoid tumor confirmed by pathology.\n\nThe presence of measurable lesions meeting RECIST 1.1 criteria.\n\nMale and female, aged ≥10 years.\n\nEastern Cooperative Oncology Group(ECOG) physical condition 0-2 points.\n\nRadiographic evidence of recurrence or disease progression within the past 6 months (according to RECIST criteria).\n\nImaging evaluation met the inoperable criteria as follows:\n\nRadical surgery will cause large defects of skin, muscle and other soft tissues, resulting in great changes in limb appearance and loss of function, or require major reconstructive surgery such as patch repair and flap repair; Radical surgery will involve the main blood vessels and nerves; The tumor involves the bone, and the safe margin cannot be achieved under the premise of bone preservation; By explaining the condition to the patient, the patient refuses to try the operation after weighing the advantages and disadvantages; Amputation is not considered.\n\nMajor organ function is normal, that is, meet the following criteria: hemoglobin (Hb) ≥ 95g/L,\n\nNeutrophil (ANC) ≥1.5×109/L, platelet count (PLT) ≥ 80×109/L,\n\nSerum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN), blood urea nitrogen (BUN) ≤ 2.5× upper limit of normal(ULN);\n\nTotal bilirubin (TB) ≤ ULN;\n\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; Albumin (ALB) ≥ 35g/L\n\nProthrombin time (PT) and partial prothrombin time (PTT) ≤1.2×ULN left ventricular ejection fraction ≥50%;\n\nPatients gave informed consent and signed a written consent form.\n\nPatients had good compliance and voluntarily accepted follow-up, treatment, laboratory tests, and other research steps as planned.\n\nExclusion Criteria:\n\nPatients who have used anlotinib, pesopanib, sorafenib, sunitinib, apatinib and other TKI drugs in the past;\n\nwith pleural effusion or ascites, causing respiratory syndrome (≥CTCAE grade 2 dyspnea \\[grade 2 dyspnea refers to shortness of breath with little activity; affects instrumental activities of daily living\\]);\n\nThe presence or current presence of other malignant tumors within 3 or 5 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane));\n\nSystemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, was planned within 4 weeks before enrollment or during the study medication period (or silk was used within 6 weeks before treatment with the trial drug) Schizomycin C). Overextended field radiotherapy (EF-RT) was performed within 4 weeks before grouping or field-limited radiotherapy to evaluate tumor lesions was performed within 2 weeks before enrollment.\n\nUnrelieved toxic reactions above CTCAE(4.0) grade 1 due to any previous treatment, excluding alopecia;\n\nwith multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);\n\nPatients with any severe and/or uncontrolled disease, including:\n\nPatients with poor blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);\n\nPatients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTC ≥480ms), or congestive heart failure grade 2 (New York Heart Association (NYHA) classification);\n\nActive or uncontrolled severe infection (≥CTCAE grade 2 infection);\n\nLiver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral therapy;\n\nRenal failure requiring hemodialysis or peritoneal dialysis;\n\nHave a history of immunodeficiency, including being HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;\n\npoor diabetes control (fasting blood glucose (FBG) \\> 10mmol/L);\n\nThe urine routine indicated urinary protein ≥++, and confirmed 24-hour urinary protein quantity \\> 1.0 g;\n\npatients with epileptic seizures requiring treatment;\n\nPatients with hypothyroidism: Thyroid stimulating hormone（TSH）\\>4.2mlU/L;\n\nSubjects with any medical condition that may increase the risk of gastrointestinal bleeding or perforation: such as active gastrointestinal ulcers, known luminal metastatic lesions, inflammatory bowel disease, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the study;\n\nKnown hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.);\n\nReceived major surgical treatment, open biopsy, or significant traumatic injury within 28 days before enrollment;\n\nPatients whose imaging showed that the tumor had invaded the periphery of important blood vessels or who were judged by the investigator to be very likely to invade important blood vessels during the subsequent study and cause fatal massive bleeding;\n\nPatients with any evidence of bleeding constitution or history, regardless of severity; Four weeks before grouping In patients with any bleeding or bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures; Significant blood coughing or daily hemoptysis of 2.5ml or more within 2 months before enrollment;\n\nExperienced an arteriovenous thrombotic event within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;\n\nAbnormal coagulation (INR \\> 1.5 or PT \\>1.2 ULN or PTT \\>1.2 ULN), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;\n\nPatients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or similar agents;\n\nThose who had received a potent CYP3A4 inhibitor within 7 days or received a potent CYP3A4 inducer within 12 days prior to study enrollment. Drugs with CYP3A4, CYP2D6, or CYP2C8 substrates should be avoided;\n\nUse drugs that may lead to prolongation of QT interval and tip torsion in ECG within 4 weeks;\n\nThose who have a history of psychotropic drug abuse and are unable to quit or have mental disorders;\n\nParticipated in clinical trials of other antitumor drugs within four weeks;\n\nPregnant or lactating patients;\n\nAny condition that, in the investigator's judgment, may impair the subject's ability to meet or perform the study requirements."}, 'identificationModule': {'nctId': 'NCT05490667', 'briefTitle': 'Clinical Study of Anlotinib Combined With Chemotherapy in the Treatment of Unresectable Advanced Desmoid Tumor', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'The Efficacy and Safety of Anlotinib Combined With Chemotherapy in the Treatment of Unresectable Advanced Desmoid Tumors: a Prospective Single-arm Clinical Study', 'orgStudyIdInfo': {'id': 'HN-STS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anlotinib', 'description': 'Anlotinib combined with chemotherapy for desmoid tumors', 'interventionNames': ['Drug: Anlotinib']}], 'interventions': [{'name': 'Anlotinib', 'type': 'DRUG', 'otherNames': ['chemotherapy'], 'description': 'Anlotinib combined with chemotherapy for desmoid tumors', 'armGroupLabels': ['Anlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Zhang', 'role': 'CONTACT', 'email': 'heartnesszp@126.com', 'phone': '13526693125'}], 'facility': 'Department of Bone and Soft Tissue ,Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate chief physician', 'investigatorFullName': 'Zhang Peng', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}