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

ConditionsAdvanced Gastric CancerGastroesophageal Junction AdenocarcinomaFruquintinibRamucirumab
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

This trial does not accept healthy volunteers

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 population

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.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

1,143 Participants
are divided into 2 treatment groups
Group A: Fruquintinib + paclitaxel1 intervention
Group B: Ramucirumab + paclitaxel1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time from randomization to progression/death, assessed via weighted Cox model

Time frame
about 3 years

Secondary outcomes

1

Objective Response Rate (ORR)

CR+PR per RECIST 1.1, compared via weighted logistic regression

Time frame
about 3 years
2

Disease Control Rate (DCR)

CR+PR+SD≥6 weeks, analyzed via weighted proportions

Time frame
about 3 years
3

Overall Survival (OS)

Time from randomization to death, analyzed using weighted Kaplan-Meier

Time frame
about 3 years
4

PFS by ECOG, metastasis burden, primary site, etc

To examine the associations between subgroup factors (including ECOG, metastasis burden, primary site, etc) and Progression-Free Survival (PFS).

Time frame
about 3 years

Other outcomes

1

Sensitivity Analyses：Progression-Free Survival (PFS)

Simulated Treatment Comparison (STC), Bootstrap confidence intervals (100 iterations)

Time frame
about 3 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: