Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT04695535
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy With Anlotinib in Advanced Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-02', 'studyFirstSubmitDate': '2020-12-28', 'studyFirstSubmitQcDate': '2021-01-02', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 3 years', 'description': 'The time from the first day of treatment until death from any cause'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Up to 3 years', 'description': 'The time from the first day of treatment until disease progression or death from any cause, or as the date of the last follow-up.'}, {'measure': 'Incidence of Adverse Events [Safety and Tolerability]', 'timeFrame': 'Up to 3 years', 'description': "Adverse Events were assessed according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 4.0."}, {'measure': 'The average score of FACT-Cx TOI [Functional Assessment]', 'timeFrame': 'Up to 3 years', 'description': 'The HRQL instruments used in this trial were the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI), for which a higher score indicates better HRQL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anlotinib', 'Chemotherapy', 'Advanced Cervical Cancer'], 'conditions': ['Uterine Cervical Neoplasms']}, 'descriptionModule': {'briefSummary': 'STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer.\n\nTRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. All the enrolled patients received chemotherapy with Anlotinib.\n\nPRIMARY ENDPOINT: Overall survival, defined as the observed length of life from entry into the study to death from any cause or the date of last contact.', 'detailedDescription': 'Patients with advanced (metastatic, persistent, and recurrent) cervical cancer will be recruited from Zhongda Hospital. Only patients who treated with paclitaxel plus nedaplatin will be included in the analysis. All patients receive paclitaxel (135-175mg /m\\^2) and nedaplatin (100 mg/m\\^2) infusion on day 1, and then take Anlotinib 12mg/d orally on day 7-21, every 3 weeks. Once patients reached CR or PR, Anlotinib was continued on 12mg/d maintenance therapy until disease progression or unacceptable toxicity was noted.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced (metastatic, persistent, and recurrent) cervical cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with advanced (metastatic, persistent, and recurrent) cervical cancer confirmed by imaging and unsuitable for surgery and radiotherapy .\n* Eastern Cooperative Oncology Group (ECOG) Performance Score(PS) 0-1\n* Estimated life expectancy \\> 3 months\n* Adequate bone marrow function: hemoglobin \\> 90 g/L, absolute neutrophil count(ANC) \\> 1.5 × 10\\^9/L, platelet \\> 80 × 10\\^9/L);\n* Adequate hepatic function: total bilirubin \\< 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\\<2.5×ULN or \\<5×ULN for patients with liver metastases;\n* Adequate renal function: serum creatinine \\< 1.5 × ULN or creatinine clearance rate (CCR) \\>60 mL/min;\n* Adequate cardiac function: left ventricular ejection fraction (LVEF) \\> 50%.\n\nExclusion Criteria:\n\n* Preexisting thyroid disease, thyroid function cannot be maintained in the normal range after treatment;\n* Have used other anti-VEGF or VEGFR-targeted drugs or received immunotherapy;\n* A history of major surgical treatment within 4 weeks, radiotherapy within 3 weeks, and concurrent chemoradiotherapy within 6 weeks;\n* Receiving hormone or immunosuppressive therapy for various reasons;\n* Inability to swallow oral medication;\n* Any malabsorption;\n* Diseases diagnosed as severe or uncontrollable within 6 months prior to the first day of treatment.\n* Participate in clinical trials of other antitumor drugs within 28 days prior to the start of study treatment;\n* The patient has comorbidities that may endanger the patient's safety or affect the patient's ability to complete the study.\n* According to the researcher's judgment, the patient has an accompanying disease that may jeopardize the patient's safety or affect the patient's ability to complete the study in the investigator's judgment."}, 'identificationModule': {'nctId': 'NCT04695535', 'briefTitle': 'Chemotherapy With Anlotinib in Advanced Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Chemotherapy With Anlotinib in Advanced Cervical Cancer: A Prospective, Single-arm Study', 'orgStudyIdInfo': {'id': 'ZhongdaH-YShen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemotherapy with Anlotinib', 'description': 'Patients received chemotherapy with Anlotinib.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhao Tao', 'role': 'CONTACT', 'email': '13057632365@126.com', 'phone': '025-83272064'}], 'facility': 'Zhongda Hospital, Affiliated to Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yang Shen, MD', 'role': 'CONTACT', 'email': 'shenyang0924@sina.cn', 'phone': '025-83262742'}], 'overallOfficials': [{'name': 'Yang Shen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yang Shen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Zhongda Hospital', 'investigatorFullName': 'Yang Shen', 'investigatorAffiliation': 'Zhongda Hospital'}}}}