Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT03654612
Status:
UNKNOWN
Last Update Posted:
2018-10-18
First Post:
2018-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}, {'id': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], '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': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '40 months', 'description': 'Progression free survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '40 months', 'description': 'Overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years old, male or female;\n2. Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);\n3. Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;\n4. According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;\n5. ECOG PS: 0-1 points;\n6. Baseline blood and biochemical indicators meet the following criteria:\n\n Hemoglobin ≥ 80g/L, Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥ 90×109/L, ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastases), Serum total bilirubin ≤ 1.5 times the normal upper limit, Serum creatinine ≤ 1.5 times the normal upper limit, Serum albumin ≥ 30g / L;\n7. The expected survival period is ≥3 months;\n8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.\n9. Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.\n\nExclusion Criteria:\n\n1. A person who has been confirmed to be allergic to apatinib and/or its excipients;\n2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male \\> 450 ms, female \\> 470 ms) and grade I cardiac insufficiency; urine protein positive patients;\n3. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);\n4. Patients who have used apatinib or tigeo in the first line\n5. abnormal blood coagulation (INR\\>1.5, APTT\\>1.5 ULN), with bleeding tendency;\n6. Patients with central nervous system metastases;\n7. Pregnant or lactating women;\n8. Patients with other malignancies within 5 years;\n9. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;\n10. Patients who have participated in other drug clinical trials within 4 weeks;\n11. Have received VEGFR inhibitors such as sorafenib and sunitinib;\n12. According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study;\n13. The investigator believes that it is not suitable for inclusion."}, 'identificationModule': {'nctId': 'NCT03654612', 'acronym': 'Y-HR2017-025', 'briefTitle': 'Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'China International Medical Foundation'}, 'officialTitle': 'A Single Arm,Open Clinical Study of Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies', 'orgStudyIdInfo': {'id': 'ChinaIMF-LP02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib+S-1', 'description': 'Patients with recurrent/metastatic head and neck malignancies received apatinib plus S-1 as second-line therapy.', 'interventionNames': ['Drug: Apatinib']}], 'interventions': [{'name': 'Apatinib', 'type': 'DRUG', 'otherNames': ['S-1'], 'description': 'Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle', 'armGroupLabels': ['Apatinib+S-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ping liu', 'role': 'CONTACT', 'email': 'cyril0820@sina.com', 'phone': '(+86)13975157508'}], 'facility': 'the Second Xiangya Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Liu Ping, doctor', 'role': 'CONTACT', 'email': 'CYRIL0820@sina.com', 'phone': '13975157508'}, {'name': 'Liu Bin, doctor', 'role': 'CONTACT', 'email': 'Binglang3351@qq.com', 'phone': '13973127325'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China International Medical Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Society of Clinical Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor in oncology', 'investigatorFullName': 'Ping Liu', 'investigatorAffiliation': 'China International Medical Foundation'}}}}