MAIC of Fruquintinib Plus Paclitaxel Versus Ramucirumab Plus Paclitaxel in Advanced G/GEJ Adenocarcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT07144995
Status
Not Yet Recruiting

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Conditions

  • Advanced Gastric Cancer
  • Fruquintinib
  • Gastroesophageal Junction Adenocarcinoma
  • Ramucirumab

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Ramucirumab+Paclitaxel — DRUG
    (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.

Study Details

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).

Key Dates

First listed
Aug 28, 2025
Start date
Sep 5, 2025
Status verified
Aug 2025
Primary completion
Aug 5, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,143 participants (estimated)

Arms

  • Arm: Fruquintinib + paclitaxel
    Group 1: Fruquintinib + Paclitaxel (IPD)
  • Arm: Ramucirumab + paclitaxel
    Group 2: Control Therapy (AgD from RAINBOW-Asia)

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: about 3 years ]

Central Contacts

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