Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-31 @ 5:10 AM
Study NCT ID:
NCT03751592
Status:
UNKNOWN
Last Update Posted:
2018-11-26
First Post:
2018-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002726', 'term': 'Chlorogenic Acid'}], 'ancestors': [{'id': 'D002934', 'term': 'Cinnamates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2018-11-19', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease control rate（DCR)', 'timeFrame': 'Within the first 10 weeks after the first dose of chlorogenic acid for injection'}], 'secondaryOutcomes': [{'measure': 'objective response rate (ORR)', 'timeFrame': 'Within the first 10 weeks after the first dose of chlorogenic acid for injection'}, {'measure': 'progress free survival(PFS)', 'timeFrame': 'Within the first 10 weeks after the first dose of chlorogenic acid for injection'}, {'measure': 'Overall Survival（OS）', 'timeFrame': 'Within the first 10 weeks after the first dose of chlorogenic acid for injection'}, {'measure': 'Eastern Cooperative Oncology Group （ECOG） score standard', 'timeFrame': 'Within the first 10 weeks after the first dose of chlorogenic acid for injection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of phase Ib/IIa of Chlorogenic acid for injection in the advanced Lung Cancer Patients.', 'detailedDescription': '1. Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;\n2. Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;\n3. Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;\n4. Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;\n5. Determine Eastern Cooperative Oncology Group（ECOG）.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18;\n2. Recurrent small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC;\n3. Estimated lifetime ≥ 3 months；\n4. Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)PLT count≥80×10\\~9/L； 2)NEUT# count≥1.5×10\\~9/L ；3)HGB count≥90g/L；4)Total bilirubin \\<=1.5 times of ULN；5)ALT/AST ≤2.5 times of ULN；\n5. Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;\n6. Volunteered for the phase 1 trial and sign the informed consent without protest.\n\nExclusion Criteria:\n\n1. Patients who suffer from other serious complication, such as uncontrollable infection, myocardial infarction within the past 6 months at the enrollment , uncontrollable hypertension ,thromboembolism and etc.;\n2. Patients with brain metastases;\n3. Patients with bone metastases;\n4. Patients who have primary immunodeficiency;\n5. Organ transplanters recipients;\n6. Patients who have received the therapy of chemotherapy within 4 weeks or radical radiotherapy with in 6 weeks before enrollment;\n7. Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;\n8. Patients who had received a therapy of another investigational drug within 1 month；\n9. Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;\n10. Patients who have received therapy of major surgery within 6 weeks or biopsy surgery within 2 weeks before enrollment;\n11. Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters；\n12. Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment;\n13. Patients who or have received radical radiotherapy within 6 weeks or local palliative radiotherapy within 2 weeks before enrollment;\n14. History of drug abuse；\n15. Patients who was treated with Immunologic drugs in 3 months;\n16. Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).'}, 'identificationModule': {'nctId': 'NCT03751592', 'briefTitle': 'Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd'}, 'officialTitle': 'A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'LYS-LC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorogenic acid, Treatment, powder', 'description': 'Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.', 'interventionNames': ['Drug: Chlorogenic acid']}], 'interventions': [{'name': 'Chlorogenic acid', 'type': 'DRUG', 'description': 'Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.', 'armGroupLabels': ['Chlorogenic acid, Treatment, powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuankai Shi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Sheng Yang, Dr', 'role': 'CONTACT', 'email': 'medart@126.com', 'phone': '8613683260156'}, {'name': 'Jianping Xu, Dr', 'role': 'CONTACT', 'email': '13651379626@139.com', 'phone': '8613651379626'}], 'overallOfficials': [{'name': 'Yuankai Shi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}