Evidence map›Paper›PMID 39671534›Full record

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

SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers.

Rachna T Shroff, Gentry King, Sarah Colby, Aaron J Scott, Mitesh J Borad, Laura Goff, Khalid Matin, Amit Mahipal, Aparna Kalyan, Milind M Javle and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter 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. It is linked to trial NCT06893380 (A Multicenter Phase 1b/2 Trial Investigating the Efficacy and Toxicity of the Combination of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Tislelizumab in Treatment Naïve Patients With Unresectable, Locally Advanced, or Metastatic BTC), which is not on this map. Cited by 94 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 4 pooled it
–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.

NCT06893380 recruitingnot on this map

A Multicenter Phase 1b/2 Trial Investigating the Efficacy and Toxicity of the Combination of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Tislelizumab in Treatment Naïve Patients With Unresectable, Locally Advanced, or Metastatic BTC

Typeobservational_patient_registrySponsorCHA UniversityRan2024 to 2026Enrolled61ConditionsLocally Advanced Biliary Tract Cancers, Metastatic Biliary Tract CancersArmsGemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab.
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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34 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

22 authors.

Rachna T ShroffUniversity of Arizona Cancer Center, Tucson, AZ.ORCID 0000-0003-0066-2672
Gentry KingFred Hutchinson Cancer Center, University of Washington, Seattle, WA.ORCID 0000-0002-7525-8802
Sarah ColbySWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA.
Aaron J ScottUniversity of Arizona Cancer Center, Tucson, AZ.ORCID 0000-0002-0301-3072
Mitesh J BoradMayo Clinic Cancer Center, Phoenix, AZ.ORCID 0000-0003-2700-2658
Laura GoffVanderbilt-Ingram Cancer Center, Nashville, TN.
Khalid MatinVirginia Commonwealth University Massey Comprehensive Cancer Center, Richmond, VA.
Amit MahipalCase Western Reserve University, Cleveland, OH.ORCID 0000-0002-1111-8333
Aparna KalyanNorthwestern University, Chicago, IL.
Milind M JavleUniversity of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-9158-0941
Imane El DikaMemorial Sloan Kettering Cancer Center, New York, NY.
Benjamin TanWashington University Siteman Cancer Center, St Louis, MO.
Puneet CheemaMetro Minnesota Community Oncology Research Consortium/Saint John's Hospital, St Louis Park, MN.ORCID 0000-0001-9024-9616
Anuj PatelDana-Farber Harvard Cancer Center, Boston, MA.ORCID 0000-0002-7045-6957
Renuka IyerRoswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0003-3643-8621
R Katie KelleyHellen Diller Family Comprehensive Cancer Center, University of California San Francisco Medical Center, San Francisco, CA.ORCID 0000-0002-1984-2430
Jaykumar ThumarYale Cancer Center, New Haven, CT.ORCID 0000-0001-9882-4574
Anthony El-KhoueiryUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.ORCID 0000-0002-9053-3841
Katherine A GuthrieSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA.
E Gabriela ChioreanFred Hutchinson Cancer Center, University of Washington, Seattle, WA.ORCID 0000-0003-3306-9592
Howard HochsterRutgers Cancer Institute, New Brunswick, NJ.ORCID 0000-0002-9893-1529
Philip A PhilipWayne State University School of Medicine/Henry Ford Cancer, Detroit, MI.ORCID 0000-0002-6513-3491

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Hutchinson Center as Lead Academic Participating Site (UG1)UG1CA233328 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Evan Yu · 2019 to 2026
$4.3M
Vanderbilt Network Lead Academic Participating Site for the NCTNUG1CA233270 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Kristen Keon Ciombor · 2019 to 2026
$3.5M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233270NCI NIH HHS UG1 CA233328
6 · The paper itself

Abstract

purposeSWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs).

methodsPatients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg/m

resultsAmong 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC. There was no significant difference in overall survival (OS) between GAP versus GC. Median OS with GAP was 14.0 months (95% CI, 12.4 to 16.1) and 13.6 months with GC (95% CI, 9.7 to 16.6); hazard ratio (HR), 0.91 (95% CI, 0.72 to 1.14);

conclusionThe addition of a taxane in the GAP regimen to the standard gemcitabine-cisplatin regimen did not improve OS in newly diagnosed BTC. More toxicity was encountered with GAP versus GC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsAdultAgedAged, 80 and overAlbuminsCisplatinDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedPaclitaxel130-nm albumin-bound paclitaxelAlbuminsCisplatinDeoxycytidineGemcitabinePaclitaxel

Identifiers

PMID39671534
PMCPMC11798714

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LicenceCC BY-NC-ND
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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.