MAIC of Fruquintinib Plus Paclitaxel Versus Ramucirumab Plus Paclitaxel in Advanced G/GEJ Adenocarcinoma
Adjusted Indirect Treatment Comparison of Fruquintinib-based Therapy Versus Standard Care in Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A MAIC Analysis.
1 other identifier
observational
1,143
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 28, 2025
August 1, 2025
11 months
August 5, 2025
August 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Time from randomization to progression/death, assessed via weighted Cox model
about 3 years
Secondary Outcomes (5)
Objective Response Rate (ORR)
about 3 years
Disease Control Rate (DCR)
about 3 years
Overall Survival (OS)
about 3 years
PFS by ECOG, metastasis burden, primary site, etc
about 3 years
OS by ECOG, metastasis burden, primary site, etc
about 3 years
Other Outcomes (1)
Sensitivity Analyses：Progression-Free Survival (PFS)
about 3 years
Study Arms (2)
Fruquintinib + paclitaxel
Group 1: Fruquintinib + Paclitaxel (IPD)
Ramucirumab + paclitaxel
Group 2: Control Therapy (AgD from RAINBOW-Asia)
Interventions
(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.
(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.
Eligibility Criteria
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.
You may qualify if:
- Histologically confirmed gastric/GEJ adenocarcinoma
- Advanced or metastatic disease
- ECOG 0-1
- Received either fruquintinib + paclitaxel or reference regimen
- Available baseline characteristics for matching variables
You may not qualify if:
- Missing key outcome data
- Incomplete baseline characteristics for \>2 matching variables
- Prior fruquintinib exposure (control arm only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Feng Wang
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 5, 2025
First Posted
August 28, 2025
Study Start
September 5, 2025
Primary Completion (Estimated)
August 5, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Within 6 months after main publication.
- Access Criteria
- Secondary analysis generated by our team require approval by an independent review committee and a signed data use agreement.
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.