Evidence map›Paper›PMID 38823398›Full record

Trial reportThe lancet. Gastroenterology & hepatology2024

Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study.

Do-Youn Oh, Aiwu Ruth He, Mohamed Bouattour, Takuji Okusaka, Shukui Qin, Li-Tzong Chen, Masayuki Kitano, Choong-Kun Lee, Jin Won Kim, Ming-Huang Chen and 33 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The lancet. Gastroenterology & hepatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 213 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
213citing papers in PubMed, 13 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.

NCT07208526 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

A Multicenter Randomized Controlled Study on Surgical Decision-Making Guided by the TDTP-RECIST Evaluation System for Locally Advanced Intrahepatic Cholangiocarcinoma Following GOLP Conversion Therapy

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2025 to 2028Enrolled270ConditionsIntrahepatic Cholangiocarcinoma (Icc), Conversion Therapy, TDTP-RECIST, GOLP RegimenArmsGOLP regimen, Surgery, TDTP-RECIST
NCT07636798 phase1 / phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (GP Regimen) and Intra-arterial Infusion of Envafolimab Combined With Lenvatinib for Unresectable Advanced First-line Biliary Tract Cancer: A Multicenter, Phase Ib/II, Single-arm Clinical Study

TypeinterventionalSponsorWest China HospitalRan2026 to 2029Enrolled20ConditionsBiliary Tract CancerArmsHAIC Combined Regimen Treatment Group
3 · Its place in the literature

Who cites it

213 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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153 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

43 authors.

Do-Youn OhDivision of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea; Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, South Korea. Electronic address: ohdoyoun@snu.ac.kr.
Aiwu Ruth HeLombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
Mohamed BouattourAssistance Publique-Hôpitaux de Paris Hôpital Beaujon, Paris, France.
Takuji OkusakaNational Cancer Center Hospital, Tokyo, Japan.
Shukui QinCancer Center of Nanjing, Jinling Hospital, Nanjing, China.
Li-Tzong ChenKaohsiung Medical University Hospital and Center for Cancer Research, Kaohsiung Medical University, Kaohsiung, Taiwan; National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan; National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
Masayuki KitanoWakayama Medical University, Wakayama, Japan.
Choong-Kun LeeYonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Jin Won KimSeoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul, South Korea.
Ming-Huang ChenTaipei Veterans General Hospital, Taipei City, Taiwan.
Thatthan SuksombooncharoenFaculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Masafumi IkedaNational Cancer Center Hospital East, Kashiwa, Japan.
Myung Ah LeeSeoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Jen-Shi ChenLinkou Chang Gung Memorial Hospital, Chang Gung University, Taoyuan City, Taiwan.
Piotr PotemskiMedical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
Howard A BurrisSarah Cannon Research Institute, Nashville, TN, USA.
Vikas OstwalTata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.
Suebpong TanasanvimonFaculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
Chigusa MorizaneNational Cancer Center Hospital, Tokyo, Japan.
Renata E ZauchaMedical University of Gdańsk, Gdańsk, Poland.
Mairéad G McNamaraDivision of Cancer Sciences, University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.
Antonio AvalloneIstituto Nazionale Tumori-IRCCS Fondazione G Pascale, Naples, Italy.
Juan E CundomInstituto de Investigaciones Metabólicas, Buenos Aires, Argentina.
Valeriy BrederN N Blokhin National Medical Research Center of Oncology, Moscow, Russia.
Benjamin TanWashington University School of Medicine, St Louis, MO, USA.
Satoshi ShimizuSaitama Cancer Center, Kita-Adachi-Gun, Saitama, Japan.
David TougeronPoitiers University Hospital, Poitiers, France.
Ludovic EvesqueCentre Antoine Lacassagne, Nice, France.
Mila PetrovaMHAT Nadezhda, Sofia, Bulgaria.
David B ZhenFred Hutchinson Cancer Center, University of Washington, Seattle, WA, USA.
Roopinder GillmoreRoyal Free Hospital, London, UK.
Vineet Govinda GuptaArtemis Hospitals, Gurugram, India.
Farshid DayyaniUniversity of California, Irvine, CA, USA.
Joon Oh ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Gary L BuchschacherKaiser Permanente Southern California, Los Angeles Medical Center, Los Angeles, CA, USA.
Felipe ReyCentro de Investigación y Desarrollo Oncológico, Clínica CIDO, Temuco, Chile.
Hyosung KimAstraZeneca, Osaka, Japan.
Julie WangAstraZeneca, New York, NY, USA.
Claire MorganAstraZeneca, Gaithersburg, MD, USA.
Nana RokutandaAstraZeneca, Gaithersburg, MD, USA.
Magdalena ŻotkiewiczAstraZeneca, Warsaw, Poland.
Arndt VogelToronto General Hospital, University Health Network and Princess Margaret Cancer Center, Toronto, ON, Canada; Hannover Medical School, Hannover, Germany.
Juan W ValleDivision of Cancer Sciences, University of Manchester and The Christie NHS Foundation Trust, Manchester, UK; Cholangiocarcinoma Foundation, Herriman, UT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the preplanned interim analysis of the TOPAZ-1 study, durvalumab plus gemcitabine-cisplatin significantly improved overall survival versus placebo plus gemcitabine-cisplatin in participants with advanced biliary tract cancer. We aimed to report updated overall survival and safety data from TOPAZ-1 with additional follow-up and data maturity beyond the interim analysis.

methodsTOPAZ-1 was a phase 3, randomised, double-masked, placebo-controlled, global study done at 105 sites in 17 countries. Participants aged 18 years or older with unresectable, locally advanced, or metastatic biliary tract cancer were randomly assigned (1:1) to durvalumab plus gemcitabine-cisplatin or placebo plus gemcitabine-cisplatin using a computer-generated randomisation scheme, stratified by disease status and primary tumour location. Participants received durvalumab (1500 mg) or placebo on day 1 of each cycle every 3 weeks for up to eight cycles, plus gemcitabine (1000 mg/m

findingsFrom April 16, 2019, to Dec 11, 2020, 914 participants were enrolled, 685 of whom were randomly assigned (341 to the durvalumab plus gemcitabine-cisplatin group and 344 to the placebo plus gemcitabine-cisplatin group). 345 (50%) participants were male and 340 (50%) were female. Median follow-up at the updated data cutoff was 23·4 months (95% CI 20·6-25·2) in the durvalumab plus gemcitabine-cisplatin group and 22·4 months (21·4-23·8) in the placebo plus gemcitabine-cisplatin group. At the updated data cutoff, 248 (73%) participants in the durvalumab plus gemcitabine-cisplatin group and 279 (81%) participants in the placebo plus gemcitabine-cisplatin group had died (median overall survival 12·9 months [95% CI 11·6-14·1] vs 11·3 months [10·1-12·5]; hazard ratio 0·76 [95% CI 0·64-0·91]). Kaplan-Meier-estimated 24-month overall survival rates were 23·6% (95% CI 18·7-28·9) in the durvalumab plus gemcitabine-cisplatin group and 11·5% (7·6-16·2) in the placebo plus gemcitabine-cisplatin group. Maximum grade 3 or 4 adverse events occurred in 250 (74%) of 338 participants in the durvalumab plus gemcitabine-cisplatin group and 257 (75%) of 342 in the placebo plus gemcitabine-cisplatin group. The most common maximum grade 3 or 4 treatment-related adverse events were decreased neutrophil count (70 [21%] vs 86 [25%]), anaemia (64 [19%] vs 64 [19%]), and neutropenia (63 [19%] vs 68 [20%]).

interpretationDurvalumab plus gemcitabine-cisplatin showed robust and sustained overall survival benefit with no new safety signals. Findings continue to support the regimen as a standard of care for people with untreated, advanced biliary tract cancer.

fundingAstraZeneca.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsCisplatinDeoxycytidineGemcitabineAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedSurvival RateAntibodies, MonoclonalCisplatinDeoxycytidinedurvalumabGemcitabine

Identifiers

PMID38823398

What OpenQuestion holds

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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.