Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-13 @ 8:28 AM
Study NCT ID:
NCT03631459
Status:
UNKNOWN
Last Update Posted:
2018-08-21
First Post:
2018-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Real World Study of Kanglaite for Cancer Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C499781', 'term': 'kang-lai-te'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2018-08-12', 'studyFirstSubmitQcDate': '2018-08-12', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': '2018 - 2020', 'description': 'Adverse events'}, {'measure': 'Serious adverse event', 'timeFrame': '2018 - 2020', 'description': 'Serious adverse event'}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2018 - 2020', 'description': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Lean body mass', 'timeFrame': '2018 - 2020', 'description': 'Lean body mass'}, {'measure': 'Body weight', 'timeFrame': '2018 - 2020', 'description': 'Body weight'}, {'measure': 'Grade of cachexia', 'timeFrame': '2018 - 2020', 'description': 'Grade of cachexia'}, {'measure': 'European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30', 'timeFrame': '2018 - 2020', 'description': 'European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30: 30 items, including functioning, symptoms, and overall health. min: 0, max: 100. The higher values indicate higher level of functioning and quality of life'}, {'measure': 'Karnofsky performance status', 'timeFrame': '2018 - 2020', 'description': 'Karnofsky performance status'}, {'measure': 'Patient-generated subjective global assessment (PG-SGA)', 'timeFrame': '2018 - 2020', 'description': 'Patient-generated subjective global assessment (PG-SGA)'}, {'measure': 'Numeric rating scale for pain', 'timeFrame': '2018 - 2020', 'description': 'Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain.'}, {'measure': 'Numeric rating scale for appetite', 'timeFrame': '2018 - 2020', 'description': 'Numeric rating scale for appetite min: 0; max: 10. The higher values indicate worse appetite'}, {'measure': 'Synergistic antitumor effect: Overall response rate', 'timeFrame': '2018 - 2020', 'description': 'Synergistic antitumor effect: Overall response rate'}, {'measure': 'Synergistic antitumor effect: Disease control rate', 'timeFrame': '2018 - 2020', 'description': 'Synergistic antitumor effect: Disease control rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kanglaita Injection/Capsule', 'Cancer cachexia', 'Real-world evidences', 'Overall survival'], 'conditions': ['Cancer Cachexia']}, 'descriptionModule': {'briefSummary': 'A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia', 'detailedDescription': 'This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients meeting international diagnostic criteria for cachexia:\n\n1. Weight loss \\> 5% over past 6 months or\n2. BMI\\<20 kg/m2 and weight loss \\> 2% or\n3. Sarcopenia and weight loss \\>2%;', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03631459', 'briefTitle': 'A Multicenter Real World Study of Kanglaite for Cancer Cachexia', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Kanglaite Pharmaceutical Co.Ltd'}, 'officialTitle': 'Safety and Effectiveness of Kanglaite Injection/Capsules for Treatment of Cancer Cachexia: A Prospective, Multicenter Real World Study of a Large Cohort of Chinese Patients', 'orgStudyIdInfo': {'id': 'KLT-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kanglaite Injection/Capsules', 'description': 'Kanglaite injection 200ml, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles', 'interventionNames': ['Drug: Kanglaite Injection/Capsules']}], 'interventions': [{'name': 'Kanglaite Injection/Capsules', 'type': 'DRUG', 'otherNames': ['Coicis oil injection, Z10970091', 'Coix seed oil triglyceride, 03004812Z'], 'description': 'Kanglaite injection 200 mL, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles', 'armGroupLabels': ['Kanglaite Injection/Capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102206', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jun Liang, MD', 'role': 'CONTACT', 'email': 'liangjun1959@aliyun.com', 'phone': '+86-010-69006900'}], 'facility': 'Peking University International Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Shukui Qin, MD', 'role': 'CONTACT', 'email': 'qinsk@csco.org.cn', 'phone': '+86-025-84453932'}], 'facility': 'NanJing PLA 81 Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Shukui Qin, MD', 'role': 'CONTACT', 'email': 'qinsk@csco.org.cn', 'phone': '0086-025-84453932'}], 'overallOfficials': [{'name': 'Shukui Qin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NanJing PLA 81 Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Kanglaite Pharmaceutical Co.Ltd', 'class': 'OTHER'}, 'collaborators': [{'name': 'NanJing PLA 81 Hospital', 'class': 'OTHER'}, {'name': 'LinkDoc Technology (Beijing) Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}