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Advanced Gastric CancerNCT07144995

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

An observational study of Advanced Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fruquintinib+Paclitaxel and Ramucirumab+Paclitaxel
How many people
1,143 participants
Where
No sites listed yet
Study dates
5 Sep 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • Missing key outcome data
  • Incomplete baseline characteristics for >2 matching variables
  • Prior fruquintinib exposure (control arm only)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Feng Wang contact

020-8734-3571

wangfeng@sysucc.org.cn

About this study

Official title: Adjusted Indirect Treatment Comparison of Fruquintinib-based Therapy Versus Standard Care in Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A MAIC Analysis.

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).

Read the detailed description

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)

Being tested
Fruquintinib+Paclitaxel, Ramucirumab+Paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fruquintinib+PaclitaxelDrug

    Also called HMPL-013+paclitaxel

    (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+PaclitaxelDrug

    Also called LY3009806 +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.

Study groups in NCT07144995
Study groupRoleWhat they receive
Fruquintinib + paclitaxelGroup 1: Fruquintinib + Paclitaxel (IPD)
Receives: Drug: Fruquintinib+Paclitaxel
Ramucirumab + paclitaxelGroup 2: Control Therapy (AgD from RAINBOW-Asia)
Receives: Drug: Ramucirumab+Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

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

    Measured: about 3 years

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

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

    Measured: about 3 years

  2. Disease Control Rate (DCR)

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

    Measured: about 3 years

  3. Overall Survival (OS)

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

    Measured: 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).

    Measured: about 3 years

  5. OS by ECOG, metastasis burden, primary site, etc

    To examine the associations between subgroup factors (including ECOG, metastasis burden, primary site, etc) and Overall Survival (OS).

    Measured: about 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start5 Sep 2025 (estimated)
  3. Primary completion5 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
1,143 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07144995
Sponsor's protocol ID
HMPL-013-FLAG-G118
Status last verified
Aug 2025
First submitted
5 Aug 2025
Last updated
28 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • An N, Chen J, Li J, Shen L, Guo W, Liu T, Li J, Qin S, Bai Y, Chen Z, Wang J, Pan Y, Xu R, Wang F. Matching-adjusted indirect comparison of fruquintinib versus ramucirumab in advanced gastric or gastroesophageal junction adenocarcinoma. J Comp Eff Res. 2026 Aug 12:e260072. doi: 10.57264/cer-2026-0072. Online ahead of print.

    PubMed 42583940

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Sun Yat-sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Feng Wang (020-8734-3571, wangfeng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: about 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07144995, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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