Evidence map›Paper›PMID 36515003›Full record

Trial reportCancer medicine2023

Randomized phase II study of capecitabine plus cisplatin with or without sorafenib in patients with metastatic gastric cancer (STARGATE).

Min-Hee Ryu, Kyung Hee Lee, Lin Shen, Kun-Huei Yeh, Changhoon Yoo, Young Seon Hong, Young Iee Park, Sung Hyun Yang, Dong Bok Shin, Dae Young Zang and 7 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 15% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Targeting ferroptosis inInternational journal of oncology · 2026
    Review
  7. Advancements in targeted therapy for gastric cancer.Therapeutic advances in gastroenterology · 2026
    Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Targeted and novel therapy in advanced gastric cancer.Experimental hematology & oncology · 2019
    Review
  18. Review
  19. Review
  20. New drug developments in metastatic gastric cancer.Therapeutic advances in gastroenterology · 2018
    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

17 authors at 12 institutions in 5 countries.

Min-Hee RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.ORCID 0000-0002-1033-1263
Kyung Hee LeeDepartment of Hemato-oncology, Yeungnam University Hospital, Daegu, South Korea.
Lin ShenDepartment of Gastrointestinal Medical Oncology, Peking University School of Oncology, Beijing Cancer Hospital and Institute, Beijing, China.ORCID 0000-0002-8798-4756
Kun-Huei YehDepartment of Oncology, National Taiwan University Hospital; and Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan.
Changhoon YooDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Young Seon HongDivision of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, South Korea.
Young Iee ParkCenter for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, South Korea.
Sung Hyun YangDepartment of Internal Medicine, Korea Cancer Center Hospital, Seoul, South Korea.
Dong Bok ShinDivision of Hematology/Oncology, Department of Internal Medicine, Gachon University Gil Hospital, Incheon, South Korea.
Dae Young ZangDivision of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Won Ki KangDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School Medicine, Seoul, South Korea.
Ik-Joo ChungDepartment of Hematology-Oncology, Chonnam National University Hwasun Hospital, Gwangju, South Korea.
Yeul Hong KimDivision of Hemato-Oncology, College of Medicine, Korea University, Anam Hospital, Seoul, South Korea.ORCID 0000-0002-2555-2333
Baek-Yeol RyooDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Byung-Ho NamBiometric Research Branch, National Cancer Center, Goyang, Gyeonggi, South Korea.
Young Soo ParkDepartment of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Ulsan College · KRChonnam National University Hospital · KRGachon University Gil Hospital · KRHallym University Medical Center · KRKorea University Medical Center · KRNational Cancer Center · KRNational Cancer Center · USNational Taiwan University Hospital · TWPeking University · CNSamsung Medical Center · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRYeungnam University Medical Center · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this randomized phase II study, we evaluated the efficacy and safety of sorafenib in combination with capecitabine and cisplatin (XP) as first-line chemotherapy in advanced gastric cancer. PATIENTS AND

methodsPatients with metastatic gastric or gastroesophageal junction adenocarcinoma were randomized (1:1) to receive either sorafenib plus XP (S + XP) or XP alone. In cases of disease progression in the XP arm, crossover to sorafenib alone was allowed. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), response rates, safety profiles, and biomarkers, and the response rates and PFS with secondline sorafenib alone after progression in the XP arm.

resultsBetween Jan 2011 and Feb 2013, a total of 195 patients were accrued (97 in the S + XP arm and 98 in the XP alone arm). The overall response rate was 54% with S + XP, and 52% with XP alone (p = 0.83). With a median follow-up of 12.6 months (range, 0.1-29.2), the median PFS assessed by independent review was 5.6 months in the S + XP arm and 5.3 months in the XP arm (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.67-1.27, p = 0.61). Overall survival was not different between the two arms (median 11.7 vs. 10.8 months; HR 0.93, 95% CI 0.65-1.31, p = 0.66). Frequencies of grade 3/4 toxicities were similar between the S + XP and XP alone arms, except for neutropenia (21% vs. 37%), anorexia (0% vs. 5%), and hand-foot skin reaction (7% vs. 1%). Among 51 patients who crossed over to sorafenib alone after disease progression in the XP arm, there was no objective response and their median PFS was 1.3 months (95% CI, 1.2-1.7).

conclusionThe addition of sorafenib to XP chemotherapy was safe but not more effective than XP alone for first-line treatment of metastatic gastric cancer.

Indexed as

Stomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCisplatinDisease ProgressionHumansSorafenibTreatment OutcomeCapecitabineCisplatinSorafenibcapecitabinechemotherapycisplatingastric cancersorafenibVEGF

Identifiers

PMID36515003
PMCPMC10134272
OpenAlexW4311479073

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.