Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-28 @ 1:23 PM
Study NCT ID:
NCT07144995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAIC of Fruquintinib Plus Paclitaxel Versus Ramucirumab Plus Paclitaxel in Advanced G/GEJ Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-01', 'size': 354572, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-05T00:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sensitivity Analyses：Progression-Free Survival (PFS)', 'timeFrame': 'about 3 years', 'description': 'Simulated Treatment Comparison (STC), Bootstrap confidence intervals (100 iterations)'}], 'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'about 3 years', 'description': 'Time from randomization to progression/death, assessed via weighted Cox model'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'about 3 years', 'description': 'CR+PR per RECIST 1.1, compared via weighted logistic regression'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'about 3 years', 'description': 'CR+PR+SD≥6 weeks, analyzed via weighted proportions'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'about 3 years', 'description': 'Time from randomization to death, analyzed using weighted Kaplan-Meier'}, {'measure': 'PFS by ECOG, metastasis burden, primary site, etc', 'timeFrame': 'about 3 years', 'description': 'To examine the associations between subgroup factors (including ECOG, metastasis burden, primary site, etc) and Progression-Free Survival (PFS).'}, {'measure': 'OS by ECOG, metastasis burden, primary site, etc', 'timeFrame': 'about 3 years', 'description': 'To examine the associations between subgroup factors (including ECOG, metastasis burden, primary site, etc) and Overall Survival (OS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Gastric Cancer', 'Gastroesophageal Junction Adenocarcinoma', 'Fruquintinib', 'Ramucirumab']}, 'descriptionModule': {'briefSummary': 'This anchored matching-adjusted indirect comparison (MAIC) evaluates the relative efficacy of fruquintinib-paclitaxel (using IPD from the FRUTIGA trial, n=703) versus ramucirumab-paclitaxel (using published AgD from RAINBOW-Asia, n=440) in advanced gastric/GEJ adenocarcinoma. Baseline characteristics are adjusted via entropy balancing weights. Primary endpoint is progression-free survival (PFS) analyzed by Bucher method; secondary endpoints include overall survival (OS) and objective response rate (ORR). Sensitivity analyses comprise restricted mean survival time (RMST) analysis and simulated treatment comparison (STC).', 'detailedDescription': 'This retrospective MAIC analysis employs individual patient data (IPD) from the FRUTIGA trial (fruquintinib arm) and published aggregate data (AgD) from RAINBOW-Asia (ramucirumab arm), with placebo as the common anchor. Pseudo individual participant data (Pseudo-IPD) for the RAINBOW-Asia trial were reconstructed from published Kaplan-Meier curves using the Guyot algorithm (2012).\n\n•Weighting Methodology: Seven prognostic factors balanced: age \\<65, male sex, ECOG 0, GEJ primary, peritoneal metastases, metastatic sites, prior doublet chemotherapy Optimization via BFGS algorithm (convergence tolerance 1e-6) Effective sample size (ESS) retention: \\> 50%\n\n•Statistical Analysis: Primary: Adjusted PFS hazard ratio (HR) using Bucher method with 95% bootstrap CI (100 iterations) Secondary: Weighted Cox models for OS; logistic regression for ORR/DCR Sensitivity: Simulated Treatment Comparison (STC) and covariate threshold analyses\n\n•Sensitivity Analyses: RMST analyses were conducted as supportive evidence alongside primary Cox models for time-to-event endpoints violating proportional hazards assumptions.\n\nRestricted mean survival time (RMST) Simulated Treatment Comparison (STC) Bootstrap confidence intervals (100 iterations)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective MAIC analysis employs individual patient data (IPD) from the FRUTIGA trial (fruquintinib arm) and published aggregate data (AgD) from RAINBOW-Asia (ramucirumab arm), with placebo as the common anchor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed gastric/GEJ adenocarcinoma\n* Advanced or metastatic disease\n* ECOG 0-1\n* Received either fruquintinib + paclitaxel or reference regimen\n* Available baseline characteristics for matching variables\n\nExclusion Criteria:\n\n* Missing key outcome data\n* Incomplete baseline characteristics for \\>2 matching variables\n* Prior fruquintinib exposure (control arm only)'}, 'identificationModule': {'nctId': 'NCT07144995', 'briefTitle': 'MAIC of Fruquintinib Plus Paclitaxel Versus Ramucirumab Plus Paclitaxel in Advanced G/GEJ Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Adjusted Indirect Treatment Comparison of Fruquintinib-based Therapy Versus Standard Care in Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A MAIC Analysis.', 'orgStudyIdInfo': {'id': 'HMPL-013-FLAG-G118'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fruquintinib + paclitaxel', 'description': 'Group 1: Fruquintinib + Paclitaxel (IPD)', 'interventionNames': ['Drug: Fruquintinib+Paclitaxel']}, {'label': 'Ramucirumab + paclitaxel', 'description': 'Group 2: Control Therapy (AgD from RAINBOW-Asia)', 'interventionNames': ['Drug: Ramucirumab+Paclitaxel']}], 'interventions': [{'name': 'Fruquintinib+Paclitaxel', 'type': 'DRUG', 'otherNames': ['HMPL-013+paclitaxel'], 'description': '(using IPD from the FRUTIGA trial, n=703) Fruquintinib：subjects received Fruquintinib orally, once daily for 3 wks on/ 1 wk off Paclitaxel：Paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle.', 'armGroupLabels': ['Fruquintinib + paclitaxel']}, {'name': 'Ramucirumab+Paclitaxel', 'type': 'DRUG', 'otherNames': ['LY3009806 +paclitaxel'], 'description': '(using published AgD from RAINBOW-Asia, n=440) Ramucirumab：8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle Paclitaxel ：Paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle.', 'armGroupLabels': ['Ramucirumab + paclitaxel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Feng Wang', 'role': 'CONTACT', 'email': 'wangfeng@sysucc.org.cn', 'phone': '020-8734-3571'}], 'overallOfficials': [{'name': 'Feng Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com', 'infoTypes': ['SAP'], 'timeFrame': 'Within 6 months after main publication.', 'ipdSharing': 'YES', 'description': 'This study utilizes aggregated data from published literature and de-identified IPD authorized by Hutchison Medipharma Limited. Secondary analysis generated by our team will be shared.', 'accessCriteria': 'Secondary analysis generated by our team require approval by an independent review committee and a signed data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Feng Wang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}