Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06940102
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appetite improvement level', 'timeFrame': 'From baseline to Week 12 (end of treatment period)', 'description': 'Proportion of subjects with an improvement in appetite based on A/CS-12 after 12 weeks of treatment'}, {'measure': 'Weight improvement level', 'timeFrame': 'From baseline to Week 12 (end of treatment period)', 'description': 'Proportion of subjects who did not lose weight relative to baseline after 12 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': 'From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first，assessed up to 24 months', 'description': 'defined as the duration from the start treatment to progression, or patient death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Megestrol Acetate', 'Nano-crystalline Megestrol Acetate', 'Targeted Therapy', 'Tyrosine Kinase Inhibitors', 'Prospective Studies', 'Observational Studies', 'Antineoplastic Agents', 'Digestive System Cancer'], 'conditions': ['Cachexia', 'Digestive System Cancer', 'Gastric Cancer', 'Colorectal Cancer', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, observational clinical study aimed at evaluating the efficacy of Megestrol Acetate for cachexia in patients with advanced digestive system tumors receiving TKI-based therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced or metastatic digestive system tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily sign a written informed consent (ICF).\n* Age ≥ 18 years at enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed locally advanced or metastatic digestive system tumors that are not amenable to curative treatment, according to the 8th edition TNM staging classification.\n* Not benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization, and planned to receive TKI-based anticancer treatment, which may be combined with chemotherapy or immunotherapy).\n* Meet the diagnostic criteria for pre-cachexia or cachexia (based on Fearon diagnostic criteria).\n* Good organ function determined\n\nExclusion Criteria:\n\n* Gastrointestinal obstruction.\n* Anorexia due to difficulty in eating caused by neurosis, mental illness, or pain.\n* Comorbidities such as severe cerebrovascular, cardiac, renal, or liver diseases.\n* Major surgery or trauma within the last month.\n* Allergy to any component of the investigational drug.\n* Other conditions deemed unsuitable by the investigator.'}, 'identificationModule': {'nctId': 'NCT06940102', 'briefTitle': 'Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy', 'orgStudyIdInfo': {'id': 'MGA-DSC-601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy', 'description': 'Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day)，TKI Therapy ± chemotherapy / immunotherapy', 'interventionNames': ['Drug: Nano-crystalline Megestrol Acetate Oral Suspension', 'Drug: TKI-Based Therapy']}, {'label': 'TKI-Based Therapy', 'description': 'TKI Therapy ± chemotherapy / immunotherapy', 'interventionNames': ['Drug: TKI-Based Therapy']}], 'interventions': [{'name': 'Nano-crystalline Megestrol Acetate Oral Suspension', 'type': 'DRUG', 'description': 'Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day)', 'armGroupLabels': ['Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy']}, {'name': 'TKI-Based Therapy', 'type': 'DRUG', 'description': 'TKI-Based Therapy', 'armGroupLabels': ['Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy', 'TKI-Based Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Liaoning Cancer Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Cheng Du', 'role': 'CONTACT', 'email': 'dc1115010@sina.com', 'phone': '024-28851942'}, {'name': 'Zhenguang Du', 'role': 'CONTACT', 'email': 'd1398@lnph.com', 'phone': '17702485727'}], 'overallOfficials': [{'name': 'Cheng Du', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The General Hospital of Northern Theater Command'}, {'name': 'Zhenguang Du', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Organizational Affiliation: Liaoning Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}