Evidence map›Paper›PMID 35895381›Full record

Trial reportCancer2022

A randomized phase 2 trial of nivolumab, gemcitabine, and cisplatin or nivolumab and ipilimumab in previously untreated advanced biliary cancer: BilT-01.

Vaibhav Sahai, Kent A Griffith, Muhammad S Beg, Walid L Shaib, Devalingam Mahalingam, David B Zhen, Dustin A Deming, Mark M Zalupski

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
11.8field-weighted citation impact, top 1% 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

36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. [Immunotherapy and Targeted Therapy for Advanced Biliary Tract Cancer].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2026
    Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Digestive cancers: mechanisms, therapeutics and management.Signal transduction and targeted therapy · 2025
    Review
  15. Review
  16. Review
  17. Review
  18. Recent Advances in Immunotherapy for Advanced Biliary Tract Cancer.Current treatment options in oncology · 2024
    Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Vaibhav SahaiDivision of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.ORCID 0000-0003-1892-1548
Kent A GriffithCenter for Cancer Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Muhammad S BegDivision of Hematology and Oncology, Department of Internal Medicine, University of Texas, Southwestern, Dallas, Texas, USA.
Walid L ShaibDepartment of Hematology and Oncology, Emory University, Atlanta, Georgia, USA.
Devalingam MahalingamDivision of Hematology and Oncology, Department of Medicine, Northwestern University, Chicago, Illinois, USA.
David B ZhenDivision of Medical Oncology, Department of Internal Medicine, University of Washington, Seattle, Washington, USA.
Dustin A DemingDivision of Hematology, Medical Oncology and Palliative Care, Department of Medicine, University of Wisconsin, Madison, Wisconsin, USA.
Mark M ZalupskiDivision of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.
University of Michigan · USEmory University · USNorthwestern University · USThe University of Texas Southwestern Medical Center · USUniversity of Washington Medical Center · USUniversity of Wisconsin System · US

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Alexey I Nesvizhskii · 1988 to 2026
$178.2M
NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

backgroundGemcitabine and cisplatin has limited benefit as treatment for advanced biliary tract cancer (BTC). The addition of an anti-programmed death receptor (PD-1)/PD-ligand (L1) antibody to either systemic chemotherapy or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody has shown benefit in multiple solid tumors.

methodsIn this phase 2 trial, patients 18 years or older with advanced BTC without prior systemic therapy and Eastern Cooperative Oncology Group Performance Status 0-1 were randomized across six academic centers. Patients in Arm A received nivolumab (360 mg) on day 1 along with gemcitabine and cisplatin on days 1 and 8 every 3 weeks for 6 months followed by nivolumab (240 mg) every 2 weeks. Patients in Arm B received nivolumab (240 mg) every 2 weeks and ipilimumab (1 mg/kg) every 6 weeks.

resultsOf 75 randomized patients, 68 received therapy (Arm A = 35, Arm B = 33); 51.5% women with a median age of 62.5 years. The observed primary outcome of 6-month progression-free survival (PFS) rates in the evaluable population was 59.4% in Arm A and 21.2% in Arm B. The median PFS and overall survival (OS) in Arm A were 6.6 and 10.6 months, and in Arm B 3.9 and 8.2 months, respectively, in patients who received any treatment. The most common treatment-related grade 3 or higher hematologic adverse event was neutropenia in 34.3% (Arm A) and nonhematologic adverse events were fatigue (8.6% Arm A) and elevated transaminases (9.1% Arm B).

conclusionsThe addition of nivolumab to chemotherapy or ipilimumab did not improve 6-month PFS. Although median OS was less than 12 months in both arms, the high OS rate at 2 years in Arm A suggests benefit in a small cohort of patients.

Indexed as

Bile Duct NeoplasmsBiliary Tract NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCisplatinDeoxycytidineFemaleGemcitabineHumansIpilimumabMaleMiddle AgedNivolumabCisplatinDeoxycytidineGemcitabineIpilimumabNivolumabchemo immunotherapybiliary cancercholangiocarcinomaimmune checkpoint blockadeimmunotherapy

Identifiers

PMID35895381
PMCPMC9540241
OpenAlexW4288051973

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.