Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT02714608
Status:
UNKNOWN
Last Update Posted:
2017-03-21
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-19', 'studyFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood routine test', 'timeFrame': 'through study completion, an average of 1 year', 'description': '0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment'}, {'measure': 'Urine routine test', 'timeFrame': 'through study completion, an average of 1 year', 'description': '0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment'}, {'measure': 'Hepatic function', 'timeFrame': 'through study completion, an average of 1 year', 'description': '0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment'}], 'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Evaluate overall survival (OS) in the 3 groups'}, {'measure': 'Time to progression(TTP)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Evaluate time to progression(TTP) in the 3 groups'}, {'measure': 'Quality of Life', 'timeFrame': 'through study completion, an average of 1 year', 'description': '\\[0 , every 4 weeks and the end of treatment\\] To determine the quality of life by using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scales.'}, {'measure': 'Symptoms scores of TCM', 'timeFrame': 'through study completion, an average of 1 year', 'description': '0 , every 4 weeks and the end of treatment'}, {'measure': 'Cancer-related fatigue', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Evaluate the fatigue degree in the 3 groups using the Chinese version of Brief Fatigue Index (BFI-C): 0 , every 4 weeks and the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)\n2. The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy.\n3. The TCM Syndrome diagnosis of Qi-Deficiency.\n4. Aged 18-75 years, both male and female.\n5. ECOG performance status 0-2.\n6. Expected to survive more than 3 months.\n7. Joined in the test voluntarily and signed the Informed consent by GCP regulation.\n\nExclusion Criteria:\n\n1. Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).\n2. Patients with significant cachexia.\n3. Untreated symptomatic brain metastases.\n\n4 .Allergic constitution, or for a variety of drug allergy.\n\n5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.\n\n6\\. Participated in other clinical trial within 3 months.\n\n7\\. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.\n\n8\\. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.\n\n9\\. Not fit for the clinical trial judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT02714608', 'briefTitle': 'A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tasly Pharmaceuticals, Inc.'}, 'officialTitle': 'A PhaseⅡa, Placebo Parallel Control, Central Randomized, Double Blind, Dosage Exploring and Multi-Center Study to Evaluate the Efficacy and Safety of Ginsenoside H Dripping Pills in Patients With Advanced NSCLC (Syndrome Of Qi-Deficiency)', 'orgStudyIdInfo': {'id': 'TCM0319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ginsenoside H dripping pills', 'description': 'Drug: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.', 'interventionNames': ['Drug: Ginsenoside H dripping pills']}, {'type': 'EXPERIMENTAL', 'label': 'Ginsenoside H dripping pills+Placebo', 'description': 'Drug: Ginsenoside H dripping pills ,Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.', 'interventionNames': ['Drug: Ginsenoside H dripping pills+Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ginsenoside H dripping pills', 'type': 'DRUG', 'description': 'Experimental: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.', 'armGroupLabels': ['Ginsenoside H dripping pills']}, {'name': 'Ginsenoside H dripping pills+Placebo', 'type': 'DRUG', 'description': 'Experimental: Drug: Ginsenoside H dripping pills+Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.', 'armGroupLabels': ['Ginsenoside H dripping pills+Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wanyin Wu', 'role': 'CONTACT'}], 'facility': 'Guangdong Provincial Hospital of TCM', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510405', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lizhu Lin', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangzhou University of TCM', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '210028', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shibing Liao', 'role': 'CONTACT'}], 'facility': 'Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueyong Wu', 'role': 'CONTACT'}], 'facility': "Jing'an District Centre Hospital of Shanghai", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201203', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Li', 'role': 'CONTACT'}], 'facility': 'Shuguang Hospital Affiliated with Shanghai University of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Zhang', 'role': 'CONTACT'}], 'facility': 'West China Hospital ,Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '644000', 'city': 'Yibin', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuming Jia', 'role': 'CONTACT'}], 'facility': "The Second People's Hospital of Yibin", 'geoPoint': {'lat': 28.7593, 'lon': 104.63994}}, {'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Yao', 'role': 'CONTACT'}], 'facility': "Tianjin People's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310002', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengyou Lin', 'role': 'CONTACT'}], 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Zhao, PhD', 'role': 'CONTACT', 'email': 'zhaomin@tasly.com', 'phone': '008613820845180'}, {'name': 'Ning Dai', 'role': 'CONTACT', 'email': 'daining@tasly.com', 'phone': '008613612187689'}], 'overallOfficials': [{'name': 'Min Zhao, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tasly Group, Co. Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tasly Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}