Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 3:28 PM
Study NCT ID:
NCT05121350
Status:
UNKNOWN
Last Update Posted:
2022-02-18
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015251', 'term': 'Epirubicin'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS) assessed by independent review committees (IRC)', 'timeFrame': 'Baseline up to 12 months', 'description': 'Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Baseline up to die', 'description': 'From randomization to the time of death from any cause'}, {'measure': 'progression free survival (PFS) assessed by investigator', 'timeFrame': 'Baseline up to 12 months', 'description': 'Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Baseline up to 6 months', 'description': 'The sum of percentage of participants with complete response rate and partial response rate'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Baseline up to 25 months', 'description': 'percentage of participants with complete response, partial response plus stable disease'}, {'measure': 'Duration of overall response (DOR)', 'timeFrame': 'Baseline up to 6 months', 'description': 'the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression'}, {'measure': 'Degradation rate', 'timeFrame': 'Baseline up to 6 months', 'description': 'Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Life expectancy \\>=3 months.\n* Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.\n* Understood and signed an informed consent form.\n\nExclusion Criteria:\n\n* Diagnosed and/or treated additional malignancy within 5 years before the first dose.\n* With factors affecting oral medication.\n* Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose.\n* A history of psychotropic drug abuse or have a mental disorder.\n* Any severe and/or uncontrolled diseas.\n* Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose.\n* Has participated in other clinical studies within 4 weeks before the first dose.\n* According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT05121350', 'briefTitle': 'A Clinical Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'ALTN-III-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arotinib hydrochloride capsule + Epirubicin', 'description': 'Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle', 'interventionNames': ['Drug: Anlotinib hydrochloride capsule', 'Drug: Epirubicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Epirubicin', 'description': 'Placebo combined with epirubicin, 21 days as a treatment cycle', 'interventionNames': ['Drug: Epirubicin', 'Drug: Arotinib hydrochloride capsule placebo']}], 'interventions': [{'name': 'Anlotinib hydrochloride capsule', 'type': 'DRUG', 'description': 'Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.', 'armGroupLabels': ['Arotinib hydrochloride capsule + Epirubicin']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': 'Epirubicin can inhibit the synthesis of DNA and RNA.', 'armGroupLabels': ['Arotinib hydrochloride capsule + Epirubicin', 'Placebo + Epirubicin']}, {'name': 'Arotinib hydrochloride capsule placebo', 'type': 'DRUG', 'description': 'Placebo of Anlotinib hydrochloride capsule', 'armGroupLabels': ['Placebo + Epirubicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohui Niu, Bachelor', 'role': 'CONTACT', 'email': 'moonlight003@163.com', 'phone': '13801132522'}], 'facility': 'Beijing Jishuitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Guo, Doctor', 'role': 'CONTACT', 'email': 'bonetumor@163.com', 'phone': '13701195504'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YUHONG ZHOU, Doctor', 'role': 'CONTACT', 'email': 'Zhou.yuhong@zs-hospital.sh.cn', 'phone': '13918286810'}], 'facility': 'Fudan University Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shanghai Niu, Bachelor', 'role': 'CONTACT', 'email': 'moonlight003@163.com', 'phone': '13801132522'}, {'name': 'YUHONG ZHOU, Doctor', 'role': 'CONTACT', 'email': 'Zhou.yuhong@zs-hospital.sh.cn', 'phone': '13918286810'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}