Evidence map›Paper›PMID 25213161›Full record

Trial reportInvestigational new drugs2015

Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.

Takayuki Yoshino, Yoshito Komatsu, Yasuhide Yamada, Kentaro Yamazaki, Akihito Tsuji, Takashi Ura, Axel Grothey, Eric Van Cutsem, Andrea Wagner, Frank Cihon and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Investigational new drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03946917 (A Multi-center, Open-label, Phase I/II Clinical Trial of Tolerability, Safety and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection), which is not on this map. Cited by 69 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 4 pooled it
4.2field-weighted citation impact, top 5% of its field
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.

NCT03946917 phase1 / phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

A Multi-center, Open-label, Phase I/II Clinical Trial of Tolerability, Safety and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection (JS001) Combined With Regorafenib in Patients With Advanced Colorectal Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2019 to 2021Enrolled44ConditionsColorectal CancerArmsJS001, regorafenib tablet
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 4 syntheses or guidelines pooled it, 119 citations in OpenAlex.

  1. Pooled it
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  5. Efficacy of hydrocolloid dressing for hand-foot skin reaction: J-SUPPORT 1701 APRON trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  20. Baseline hypoalbuminemia enhances regorafenib-induced problematic fatigue development in real-world metastatic colorectal cancer treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article

9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 11 institutions in 5 countries.

Takayuki YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, 277-8577, Chiba, Japan, tyoshino@east.ncc.go.jp.
Yoshito Komatsu
Yasuhide Yamada
Kentaro Yamazaki
Akihito Tsuji
Takashi Ura
Axel Grothey
Eric Van Cutsem
Andrea Wagner
Frank Cihon
Yoko Hamada
Atsushi Ohtsu
National Cancer Center Hospital East · JPAichi Cancer Center · JPBayer (Germany) · DEBayer (Japan) · JPBayer (United States) · USCHI Health · USHokkaido University Hospital · JPKU Leuven · BENational Cancer Center · USShizuoka Cancer Center · JPWinnMed · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the international, phase III, randomized, double-blind CORRECT trial, regorafenib significantly prolonged overall survival (OS) versus placebo in patients with metastatic colorectal cancer (mCRC) that had progressed on all standard therapies. This post hoc analysis evaluated the efficacy and safety of regorafenib in Japanese and non-Japanese subpopulations in the CORRECT trial.

methodsPatients were randomized 2 : 1 to regorafenib 160 mg once daily or placebo for weeks 1-3 of each 4-week cycle. The primary endpoint was OS. Outcomes were assessed using descriptive statistics.

resultsOne hundred Japanese and 660 non-Japanese patients were randomized to regorafenib (n = 67 and n = 438) or placebo (n = 33 and n = 222). Regorafenib had a consistent OS benefit in the Japanese and non-Japanese subpopulations, with hazard ratios of 0.81 (95 % confidence interval [CI] 0.43-1.51) and 0.77 (95 % CI 0.62-0.94), respectively. Regorafenib-associated hand-foot skin reaction, hypertension, proteinuria, thrombocytopenia, and lipase elevations occurred more frequently in the Japanese subpopulation than in the non-Japanese subpopulation, but were generally manageable.

conclusionRegorafenib appears to have comparable efficacy in Japanese and non-Japanese subpopulations, with a manageable adverse-event profile, suggesting that this agent could potentially become a standard of care in patients with mCRC.

Indexed as

Asian PeopleAdultAgedAged, 80 and overAntineoplastic AgentsArea Under CurveBody Mass IndexColorectal NeoplasmsDemographyFemaleHumansMaleMiddle AgedNeoplasm MetastasisPhenylurea CompoundsPlacebosAntineoplastic AgentsPhenylurea CompoundsPlacebosPyridinesregorafenib

Identifiers

PMID25213161
PMCPMC4434855
OpenAlexW2054301472

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.