Evidence map›Paper›PMID 32463975›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2020

Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study.

Nai-Jung Chiang, Ming-Huang Chen, Shih-Hung Yang, Chiun Hsu, Chia-Jui Yen, Hsiao-Hui Tsou, Yung-Yeh Su, Jen-Shi Chen, Yan-Shen Shan, Li-Tzong Chen

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02425137 (A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-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.

NCT02425137 phase2completednot on this map

A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer

TypeinterventionalSponsorTTY BiopharmRan2015 to 2017Enrolled51ConditionsAdvanced Biliary Tract Cancer(BTC)ArmsS-1/Gemcitabine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Trial
  3. Article
  4. Review
  5. DEB-TACE with irinotecanFrontiers in bioengineering and biotechnology · 2022
    Article
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

10 authors at 6 institutions in 1 country.

Nai-Jung ChiangInstitute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.ORCID 0000-0003-2743-9702
Ming-Huang ChenDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Shih-Hung YangDepartment of Oncology, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan.
Chiun HsuDepartment of Oncology, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan.
Chia-Jui YenInstitute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Hsiao-Hui TsouInstitute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.ORCID 0000-0001-6773-4111
Yung-Yeh SuInstitute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Jen-Shi ChenDivision of Hematology and Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.
Yan-Shen ShanInstitute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Li-Tzong ChenNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.ORCID 0000-0003-3250-7167
National Health Research Institutes · TWNational Cheng Kung University Hospital · TWNational Taiwan University Hospital · TWChang Gung University · TWKaohsiung Medical University · TWNational Yang Ming Chiao Tung University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsGemcitabine plus cisplatin (GC) remains the standard, frontline therapy for advanced biliary tract cancer (ABTC). The JCOG1113 study suggested that gemcitabine plus S-1 (GS) had noninferior median overall survival and comparable incidence of significant neutropenia as compared to GC treatments. This study evaluates the efficacy and safety of a modified GS regimen.

methodsThe eligible patients with chemonaive, measurable ABTC received 800 mg/m

resultsFifty-one patients were enrolled and most of them had intrahepatic cholangiocarcinoma (64.7%), metastatic disease (84.3%) and disease-related symptoms (82.4%). On intention-to-treat analysis, 11 (21.6%) patients showed partial response, whereas 21 (41.2%) showed stable disease ≥ 12 weeks. The progression-free and overall survival were 5.4 months (95% confidence interval [CI]: 3.5-7.0), and 12.7 months (95% CI: 6.1-15.6) respectively. The study met its primary endpoint with a 12-week DCR of 69.6% in 46 evaluable patients. Grade 3/4 treatment-related adverse eventsoccurred in < 6% of patients of all individual items. The mean dose intensities of S-1 and gemcitabine were 87.1% and 92.5% respectively.

conclusionsModified GS showed moderate efficacy with a favourable safety profile in ABTC patients, thus mandating further assessment. ClinicalTrials.gov number: NCT02425137.

Indexed as

Bile Duct NeoplasmsBiliary Tract NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCisplatinDeoxycytidineDisease-Free SurvivalGemcitabineHumansTreatment OutcomeCisplatinDeoxycytidineGemcitabinebiliary tract cancergemcitabineS-1

Identifiers

PMID32463975
PMCPMC7540301
OpenAlexW3031971387

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.