Evidence map›Paper›PMID 37906316›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2024

Second-line chemoimmunotherapy with nivolumab and paclitaxel in immune-related biomarker-enriched advanced gastric cancer: a multicenter phase Ib/II study.

Choong-Kun Lee, Jii Bum Lee, Se Jung Park, Jingmin Che, Woo Sun Kwon, Hyo Song Kim, Minkyu Jung, Seulkee Lee, Sook Ryun Park, Dong-Hoe Koo and 8 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
3.9field-weighted citation impact, top 6% 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.

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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Observational
  8. Review
  9. Predictive value of EBV-positivity in patients with gastric cancer treated with first-line nivolumab plus chemotherapy.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Article
  10. Article
  11. 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

18 authors at 7 institutions in 1 country.

Choong-Kun LeeDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, South Korea.
Jii Bum LeeDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, South Korea.
Se Jung ParkSondang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea.
Jingmin CheSondang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea.
Woo Sun KwonSondang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea.
Hyo Song KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, South Korea.
Minkyu JungDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, South Korea.
Seulkee LeeDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Sook Ryun ParkDivision of Oncology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Dong-Hoe KooDivision of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Hyun Woo LeeDepartment of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
Woo Kyun BaeDivision of Hematology and Oncology, Department of Internal Medicine, Chonnam National University Medical School and Hwasun Hospital, Jeonnam, South Korea.
Hei-Cheul JeungDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
In Gyu HwangDepartment of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea.
Hyunki KimDepartment of Pathology, Yonsei University College of Medicine, Seoul, South Korea.
Chung Mo NamDepartment of Preventive Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Hyun Cheol ChungDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, South Korea.
Sun Young RhaDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, South Korea. RHA7655@yuhs.ac.ORCID 0000-0002-2512-4531
Yonsei University · KRAjou University · KRChonnam National University Hwasun Hospital · KRChung-Ang University Hospital · KRKangbuk Samsung Hospital · KRSamsung Medical Center · KRUlsan College · KR

Funding

Basic Science Research Program, through the National Research Foundation of Korea (NRF), funded by the Ministry of Science, ICT & Future Planning 2017R1A2B200577National R&D Program for Cancer Control, Ministry of Health and Welfare, Republic of Korea 1520190National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) NRF-2020R1C1C1004461
6 · The paper itself

Abstract

backgroundWe conducted a trial to evaluate the efficacy and safety of nivolumab and paclitaxel as second-line therapy for immune-related biomarker-enriched advanced gastric cancer (AGC).

methodsThis open-label, single-arm, phase Ib/II study was a part of multi-institutional, biomarker-integrated umbrella study conducted in Korea. In phase Ib, patients received nivolumab (3 mg/kg) on Days 1 and 15 and paclitaxel (dose level 1, 70 mg/m

resultsDose level 2 was selected as RP2D. In phase II, 48 patients were enrolled. The median PFS and OS were 3.9 and 11.2 months, respectively. The ORR was 23.3%, and the median response duration was 16.7 months. Grade 3 or higher treatment-related adverse events, mainly neutropenia, occurred in 20 patients (41.7%). Targeted sequencing revealed that patients with RTK/RAS pathway alterations or the HLA-A02 supertype had better survival. Patients with elevated baseline interleukin-1 receptor antagonist levels had worse survival.

conclusionsAlthough the study did not meet its primary end point, nivolumab and paclitaxel for AGC demonstrated a durable response with manageable toxicity profiles. Genomic analysis or plasma cytokine analysis may provide information for the selection of patients who would benefit more from immunotherapy combined with chemotherapy.

Indexed as

Epstein-Barr Virus InfectionsStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBiomarkersHerpesvirus 4, HumanHumansImmunotherapyNivolumabPaclitaxelBiomarkersNivolumabPaclitaxelAdvanced gastric cancerBiomarker enrichedImmune checkpoint inhibitorsNivolumabPaclitaxel

Identifiers

PMID37906316
OpenAlexW4388140660

What OpenQuestion holds

Textmetadata
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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.