Evidence map›Paper›PMID 40408613›Full record

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

Randomized Phase III Trial of Ramucirumab Beyond Progression Plus Irinotecan in Patients With Ramucirumab-Refractory Advanced Gastric Cancer: RINDBeRG Trial.

Daisuke Sakai, Shigenori Kadowaki, Ryohei Kawabata, Hiroki Hara, Hironaga Satake, Masazumi Takahashi, Atsushi Takeno, Hiroo Imai, Keiko Minashi, Takeshi Kawakami and 9 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Efficacy and safety of irinotecan-based therapy in elderly patients with advanced gastric cancer receiving third-line or later chemotherapy: post-hoc age-subgroup analysis of the rindberg trial.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
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  5. Review
  6. Review
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

19 authors.

Daisuke SakaiOsaka International Cancer Institute, Osaka, Japan.ORCID 0000-0002-9436-7553
Shigenori KadowakiAichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0001-9923-5309
Ryohei KawabataOsaka Rosai Hospital, Sakai, Japan.
Hiroki HaraSaitama Cancer Center, Ina, Japan.ORCID 0000-0003-3881-9815
Hironaga SatakeKobe City Medical Center General Hospital, Kobe, Japan.ORCID 0000-0001-7629-6803
Masazumi TakahashiYokohama Municipal Citizen's Hospital, Yokohama, Japan.ORCID 0000-0002-5123-9914
Atsushi TakenoNational Hospital Organization Osaka National Hospital, Osaka, Japan.
Hiroo ImaiTohoku University Hospital, Sendai, Japan.
Keiko MinashiChiba Cancer Center, Chiba, Japan.ORCID 0000-0003-1513-7117
Takeshi KawakamiShizuoka Cancer Center, Sunto-gun, Japan.ORCID 0000-0001-9385-9516
Shogen BokuKansai Medical University Hospital, Hirakata, Japan.ORCID 0000-0002-5015-0379
Jin MatsuyamaHigashiosaka City Medical Center, Higashi-Osaka, Japan.
Yasuhiro SakamotoOsaki Citizen Hospital, Osaki, Japan.
Kentaro SawadaKushiro Rosai Hospital, Kushiro, Japan.ORCID 0000-0001-7952-2765
Masato KataokaNational Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Hisato KawakamiTohoku University Hospital, Sendai, Japan.ORCID 0000-0002-3280-4850
Toshio ShimokawaWakayama Medical University, Wakayama, Japan.
Narikazu BokuIMSUT Hospital, Institute of Medical Science, University of Tokyo, Tokyo, Japan.ORCID 0000-0002-1438-707X
Taroh SatohOsaka University Hospital, Suita, Japan.ORCID 0000-0002-4615-2638

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeContinuous use of antiangiogenic agents has demonstrated survival benefits in various cancers. This trial aimed to compare the efficacy and safety of ramucirumab plus irinotecan with irinotecan monotherapy as a third- or later-line treatment for patients with advanced or recurrent gastric or gastroesophageal cancer (AGC) that has progressed on previous ramucirumab-based chemotherapy.

methodsPatients age 20 years and older with AGC, who had experienced disease progression during ramucirumab-based chemotherapy, were randomly assigned to receive either ramucirumab plus irinotecan or irinotecan monotherapy. The primary end point was overall survival (OS) expecting a hazard ratio (HR) of 0.77 (a power of 80% and a significance level of one-sided 0.05). Secondary end points included progression-free survival (PFS), response rate, disease control rate (DCR), and safety.

resultsBetween February 2017 and August 2022, 402 patients in Japan were randomly assigned to receive ramucirumab plus irinotecan (n = 202) or irinotecan monotherapy (n = 200). The median OS was 9.4 months in the combination arm and 8.5 months in the monotherapy arm, with an adjusted HR of 0.91 (95% CI, 0.74 to 1.12;

conclusionAdding ramucirumab to irinotecan does not provide a significant advantage in OS over irinotecan alone in patients with AGC who have progressed during ramucirumab-containing chemotherapy.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsIrinotecanStomach NeoplasmsAdultAgedAged, 80 and overDisease ProgressionDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedProgression-Free SurvivalRamucirumabAntibodies, Monoclonal, HumanizedIrinotecanRamucirumab

Identifiers

PMID40408613
PMCPMC12199805

What OpenQuestion holds

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Registered trials

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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.