Evidence map›Paper›PMID 39365958›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

INTEGRATE IIa Phase III Study: Regorafenib for Refractory Advanced Gastric Cancer.

Nick Pavlakis, Kohei Shitara, Katrin Sjoquist, Andrew Martin, Anthony Jaworski, Niall Tebbutt, Yung-Jue Bang, Thierry Alcindor, Chris O'Callaghan, Andrew Strickland and 11 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Health-related quality-of-life outcomes with regorafenib in advanced gastric and esophagogastric junction cancer: results from the INTEGRATE trials.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Nick PavlakisDepartment of Medical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia.ORCID 0000-0002-1738-0316
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa City, Japan.ORCID 0000-0001-5196-3630
Katrin SjoquistNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0001-9028-8682
Andrew MartinNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Anthony JaworskiNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Niall TebbuttOlivia Newton-John Cancer Wellness & Research Centre, Melbourne, VIC, Australia.ORCID 0000-0003-2613-5168
Yung-Jue BangSeoul National University College of Medicine, Seoul, South Korea.ORCID 0000-0001-6000-4597
Thierry AlcindorMcGill University Health Centre, Montreal, QC, Canada.ORCID 0000-0002-6004-0405
Chris O'CallaghanCanadian Cancer Trials Group, Queens University, Kingston, ON, Canada.
Andrew StricklandDepartment of Medical Oncology, Monash Health, Monash University, Melbourne, VIC, Australia.
Sun Young RhaYonsei Cancer Centre, Yonsei University Health System, Seoul, South Korea.ORCID 0000-0002-2512-4531
Keun-Wook LeeSeoul National University College of Medicine, Seoul, South Korea.ORCID 0000-0002-8491-703X
Jin-Soo KimDepartment of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea.ORCID 0000-0003-2636-2352
Li-Yuan BaiDivision of Hematology and Oncology, China Medical University Hospital, Taichung, Taiwan.ORCID 0000-0001-7739-4077
Hiroki HaraSaitama Cancer Center, Saitama, Japan.ORCID 0000-0003-3881-9815
Do-Youn OhSeoul National University Hospital, Cancer Research Institute, Jongno-gu, Seoul National University College of Medicine, South Korea.ORCID 0000-0003-1663-9901
Sonia YipNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.ORCID 0009-0001-2574-487X
John ZalcbergDepartment of Medical Oncology, Alfred Health, Melbourne, VIC, Australia.ORCID 0000-0002-6624-0782
Tim PriceThe Queen Elizabeth Hospital, Adelaide, SA, Australia.ORCID 0000-0002-3922-2693
John SimesNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
David GoldsteinNelune Cancer Centre, Prince of Wales Hospital, Sydney, NSW, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTreatment options for refractory advanced gastric and esophagogastric junction cancer (AGOC) are limited. Regorafenib, an oral multikinase inhibitor, prolonged progression-free survival (PFS) versus placebo in the INTEGRATE I phase II trial. INTEGRATE IIa was designed to examine whether regorafenib improved overall survival (OS).

methodsA double-blind placebo-controlled phase III trial compared regorafenib and best supportive care (BSC) versus placebo and BSC for participants with confirmed evaluable metastatic/advanced AGOC who failed ≥two prior therapies on a 2:1 random assignment, stratified by tumor location, geographic region (Asia

resultsINTEGRATE IIa enrolled 251 participants: 157 from Asia and 94 from rest of world and 169 received regorafenib and 82 received placebo. No significant heterogeneity was observed between INTEGRATE I and INTEGRATE IIa studies on OS. Pooled OS analysis hazard ratio (HR) was 0.70 (95% CI, 0.56 to 0.87;

conclusionRegorafenib improves survival compared with placebo in refractory AGOC.

Indexed as

Antineoplastic AgentsPhenylurea CompoundsPyridinesStomach NeoplasmsAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedProgression-Free SurvivalQuality of LifeAntineoplastic AgentsPhenylurea CompoundsPyridinesregorafenib

Identifiers

PMID39365958

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.