fruquintinib+paclitaxel
Drug(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.
Other names: HMPL-013+paclitaxel
NCT Number: NCT07144995
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).
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Get Notified18 year and older
All sexes
Observational
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).
•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%
•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
•Sensitivity Analyses: RMST analyses were conducted as supportive evidence alongside primary Cox models for time-to-event endpoints violating proportional hazards assumptions.
Restricted mean survival time (RMST) Simulated Treatment Comparison (STC) Bootstrap confidence intervals (100 iterations)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(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.
Other names: HMPL-013+paclitaxel
(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.
Other names: LY3009806 +paclitaxel
Time frame: about 3 years
Time from randomization to progression/death, assessed via weighted Cox model
Time frame: about 3 years
CR+PR per RECIST 1.1, compared via weighted logistic regression
Time frame: about 3 years
CR+PR+SD≥6 weeks, analyzed via weighted proportions
Time frame: about 3 years
Time from randomization to death, analyzed using weighted Kaplan-Meier
Time frame: about 3 years
To examine the associations between subgroup factors (including ECOG, metastasis burden, primary site, etc) and Progression-Free Survival (PFS).
Time frame: about 3 years
To examine the associations between subgroup factors (including ECOG, metastasis burden, primary site, etc) and Overall Survival (OS).
Time frame: about 3 years
Simulated Treatment Comparison (STC), Bootstrap confidence intervals (100 iterations)
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
Adjusted Indirect Treatment Comparison of Fruquintinib-based Therapy Versus Standard Care in Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A MAIC Analysis.
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