MAIC of Fruquintinib Plus Paclitaxel Versus Ramucirumab Plus Paclitaxel in Advanced G/GEJ Adenocarcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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).
Eligibility criteria
Qualifiers
Histologically confirmed gastric/GEJ adenocarcinoma
Advanced or metastatic disease
ECOG 0-1
Received either fruquintinib + paclitaxel or reference regimen
Disqualifiers
Missing key outcome data
Incomplete baseline characteristics for >2 matching variables
Prior fruquintinib exposure (control arm only)
Trial design
Treatments tested in this trial
- Fruquintinib+Paclitaxel
- Ramucirumab+Paclitaxel
Treatment groups
1,143 Participants
are divided into 2 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
Sun Yat-sen University
Lead sponsor
Source ClinicalTrials.gov