Evidence map›Paper›PMID 30578687›Full record

Trial reportHepatology (Baltimore, Md.)2019

Tremelimumab in Combination With Microwave Ablation in Patients With Refractory Biliary Tract Cancer.

Changqing Xie, Austin G Duffy, Donna Mabry-Hrones, Bradford Wood, Elliot Levy, Venkatesh Krishnasamy, Javed Khan, Jun S Wei, David Agdashian, Manoj Tyagi and 14 more

Registry-linked trialOpen access · greenAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01853618 (A Pilot Study of Tremelimumab - A Monoclonal Antibody Against CTLA-4 in Combination With Trans-Arterial Catheter Chemoembolization), which is not on this map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
8.8field-weighted citation impact, top 2% 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.

NCT01853618 phase1 / phase2completednot on this map

A Pilot Study of Tremelimumab - A Monoclonal Antibody Against CTLA-4 in Combination With Trans-Arterial Catheter Chemoembolization (TACE), Radiofrequency Ablation (RFA), or Cryoablation in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2017Enrolled61ConditionsHeptocellular Cancer, Biliary Tract Neoplasms, Liver Cancer, Hepatocellular CarcinomaArmsTremelimumab, RFA, TACE, Cryoablation
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 100 citations in OpenAlex.

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  11. Recent Advances in Immunotherapy for Advanced Biliary Tract Cancer.Current treatment options in oncology · 2024
    Review
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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

24 authors at 6 institutions in 3 countries.

Changqing XieHematology/Oncology Fellowship Program, National Heart, Lung, and Blood Institute/National Cancer Institute, National Institutes of Health, Bethesda, MD.
Austin G DuffyGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Donna Mabry-HronesGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Bradford WoodRadiology and Imaging Sciences, Center for Cancer Research, National Institutes of Health, Bethesda, MD.
Elliot LevyRadiology and Imaging Sciences, Center for Cancer Research, National Institutes of Health, Bethesda, MD.
Venkatesh KrishnasamyRadiology and Imaging Sciences, Center for Cancer Research, National Institutes of Health, Bethesda, MD.
Javed KhanGenetics Branch, Center for Cancer Research, NCI, NIH, Bethesda, MD.
Jun S WeiGenetics Branch, Center for Cancer Research, NCI, NIH, Bethesda, MD.
David AgdashianGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Manoj TyagiGenetics Branch, Center for Cancer Research, NCI, NIH, Bethesda, MD.
Vineela GangalapudiGenetics Branch, Center for Cancer Research, NCI, NIH, Bethesda, MD.
Suzanne FioravantiGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Melissa WalkerGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Victoria AndersonRadiology and Imaging Sciences, Center for Cancer Research, National Institutes of Health, Bethesda, MD.
David VenzonBiostatistics and Data Management Section, NCI, NIH, Bethesda, MD.
William D FiggClinical Pharmacology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Milan SandhuGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
David E KleinerLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Maria Pia MorelliHematology/Oncology Fellowship Program, National Heart, Lung, and Blood Institute/National Cancer Institute, National Institutes of Health, Bethesda, MD.
Charalampos S FloudasHematology/Oncology Fellowship Program, National Heart, Lung, and Blood Institute/National Cancer Institute, National Institutes of Health, Bethesda, MD.
Gagandeep BrarHematology/Oncology Fellowship Program, National Heart, Lung, and Blood Institute/National Cancer Institute, National Institutes of Health, Bethesda, MD.
Seth M SteinbergBiostatistics and Data Management Section, Center for Cancer Research, National Institutes of Health, Bethesda, MD.
Firouzeh KorangyGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Tim F GretenGastrointestinal Malignancies Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Center for Cancer Research · USNational Cancer Institute · USNational Institutes of Health · USNational Heart Lung and Blood Institute · USCancer Institute (WIA) · INData Management (Italy) · IT

Funding

Postmortem PathologyZICBC010685 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KLEINER, DAVID ERWIN · 2009 to 2025
$14.3M
Clinical protocols for the treatment of GI cancerZIABC011343 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GRETEN, TIM · 2010 to 2025
$4.8M
Intramural NIH HHS ZIA BC011343
6 · The paper itself

Abstract

Treatment options for patients with advanced biliary tract cancer are limited. Dysregulation of the immune system plays an important role in the pathogenesis of biliary tract cancer (BTC). This study aimed to investigate whether tremelimumab, an anti-CTLA4 (cytotoxic T-lymphocyte-associated protein 4) inhibitor, could be combined safely with microwave ablation to enhance the effect of anti-CTLA4 treatment in patients with advanced BTC. Patients were enrolled to receive monthly tremelimumab (10 mg/kg, intravenously) for six doses, followed by infusions every 3 months until off-treatment criteria were met. Thirty-six days after the first tremelimumab dose, patients underwent subtotal microwave ablation. Interval imaging studies were performed every 8 weeks. Adverse events (AEs) were noted and managed. Tumor and peripheral blood samples were collected to perform immune monitoring and whole-exome sequencing (WES). Twenty patients with refractory BTC were enrolled (median age, 56.5 years). No dose-limiting toxicities were encountered. The common treatment-related AEs included lymphopenia, diarrhea, and elevated transaminases. Among 16 patients evaluable for efficacy analysis, 2 (12.5%) patients achieved a confirmed partial response (lasting for 8.0 and 18.1 months, respectively) and 5 patients (31.3%) achieved stable disease. Median progression free survival (PFS) and overall survival (OS) were 3.4 months (95% confidence interval [CI], 2.5-5.2) and 6.0 months (95% CI, 3.8-8.8), respectively. Peripheral blood immune cell subset profiling showed increased circulating activated human leukocyte antigen, DR isotype ([HLA-DR] positive) CD8

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiliary Tract NeoplasmsCarcinomaFemaleHumansMaleMicrowavesMiddle AgedRadiofrequency TherapyTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agentstremelimumab

Identifiers

PMID30578687
PMCPMC6461476
OpenAlexW2905910693

What OpenQuestion holds

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LicenceTDM
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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.