Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT06963593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Treatment of Anorexia and Cachexia in Advanced Gastric and Esophageal Cancer With Nanosized Megestrol Acetate Combined With Immunochemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Quality of Life for Patients with Advanced Gastric Cancer and Esophageal Cancer', 'timeFrame': '1year', 'description': "Quality of Life Questionnaire (EORTC QLQ-C30; Physicians' Global Assessment score). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument, assesses health-related quality of life in cancer patients. The scale assesses 15 domains: 5 functional scales, 3 symptom scales, 6 single-item measures, and 1 global quality of life scale. Compared to baseline, a score change of ≥10 points in functional scales or the global quality of life scale indicates clinical significance (higher scores represent better functioning or quality of life). For symptom scales/single-item measures, a score increase ≥10 points signifies deterioration (higher scores indicate more severe symptoms or problems). An improvement is defined as either a ≥10-point increase in functional scale scores or a ≥10-point decrease in symptom scale scores."}, {'measure': 'Changes in Body Weight Relative to Baseline in Patients with Advanced Gastric and Esophageal Cancers', 'timeFrame': '1year', 'description': '1. Body weight (kg);\n2. Height (m);\n3. BMI (kg/m², calculated from weight and height).'}], 'secondaryOutcomes': [{'measure': 'Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers', 'timeFrame': '1year', 'description': 'Progression-Free Survival'}, {'measure': 'Impact on Survival Benefits in Patients with Advanced Gastric and Esophageal Cancers', 'timeFrame': '1year', 'description': 'Overall Survival'}, {'measure': 'Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers', 'timeFrame': '1year', 'description': 'L3-CT (Skeletal Muscle）'}, {'measure': 'Impact on Body Composition in Patients with Advanced Gastric and Esophageal Cancers', 'timeFrame': '1year', 'description': 'Appetite (Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale 12, FAACT-A/CS-12)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Gastroesophageal Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized, parallel-controlled, multicenter clinical study. The purpose of this study is to evaluate the efficacy and safety of nanocrystalline megestrol acetate combined with the first-line standard immunochemotherapy regimen compared with the first-line standard immunochemotherapy regimen in the treatment of anorexia and cachexia in advanced gastric and esophageal cancer. Eligible patients with gastric and esophageal cancer will be randomly assigned in a 1:1 ratio to the nanocrystalline megestrol acetate combination group (referred to as the megestrol acetate group for short) or the first-line standard immunochemotherapy group (referred to as the standard control group for short).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Aged between 18 and 75 years old, regardless of gender；\n2. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2；\n3. The expected survival time is more than 3 months；\n4. Good organ function'}, 'identificationModule': {'nctId': 'NCT06963593', 'briefTitle': 'Clinical Study on the Treatment of Anorexia and Cachexia in Advanced Gastric and Esophageal Cancer With Nanosized Megestrol Acetate Combined With Immunochemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Efficacy and Safety of Nanosized Megestrol Acetate Combined With Immunochemotherapy in the Treatment of Anorexia and Cachexia in Advanced Gastric and Esophageal Cancer: A Randomized, Controlled, Multicenter Study', 'orgStudyIdInfo': {'id': '2025YJZ29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Megestrol Acetate Group', 'interventionNames': ['Drug: Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen']}, {'type': 'OTHER', 'label': 'First-Line Standard Immuno-Chemotherapy Regimen', 'description': 'Control Group', 'interventionNames': ['Drug: First-Line Standard Immuno-Chemotherapy Regimen']}], 'interventions': [{'name': 'Nanocrystal Megestrol Acetate in Combination with First-Line Standard Immuno-Chemotherapy Regimen', 'type': 'DRUG', 'description': 'Megestrol Acetate Nanocrystal Oral Suspension Group: Nanocrystal Megestrol Acteate Oral Suspension (QD, up to 16 weeks from the initiation of immuno-chemotherapy) + PD-1 inhibitor (Q3W, until PD) + Chemotherapy regimen (TP regimen or XELOX regimen or SOX regimen selected based on cancer type, Q3W, as per package insert)', 'armGroupLabels': ['Megestrol Acetate Group']}, {'name': 'First-Line Standard Immuno-Chemotherapy Regimen', 'type': 'DRUG', 'description': 'PD-1 inhibitor (Q3W, until PD) + Chemotherapy regimen (TP regimen or XELOX regimen or SOX regimen selected based on cancer type, Q3W, as per package insert)', 'armGroupLabels': ['First-Line Standard Immuno-Chemotherapy Regimen']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shen Lin', 'role': 'CONTACT', 'email': 'doctorshenlin@sina.cn', 'phone': '15801503311'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}