Evidence map›Paper›PMID 32453456›Full record

Trial reportCancer2020

A multi-institutional phase 2 trial of regorafenib in refractory advanced biliary tract cancer.

Richard D Kim, Hanna K Sanoff, Andrew S Poklepovic, Heloisa Soares, Jongphil Kim, Jing Lyu, Yingmiao Liu, Andrew B Nixon, Dae Won Kim

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Sunitinib as Second-Line Treatment in Advanced Intrahepatic Cholangiocarcinoma: Results From the SUN-CK GERCOR Phase II Trial.Liver international : official journal of the International Association for the Study of the Liver · 2025
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  9. Research progress on prognostic factors of gallbladder carcinoma.Journal of cancer research and clinical oncology · 2024
    Review
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  11. Review
  12. Article
  13. Article
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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

9 authors at 5 institutions in 1 country.

Richard D KimDepartment of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0002-8448-844X
Hanna K SanoffDepartment of Medicine, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, USA.ORCID 0000-0001-8679-4486
Andrew S PoklepovicDepartment of Medicine, Virginia Commonwealth University Health System, Richmond, Virginia, USA.ORCID 0000-0002-4015-5037
Heloisa SoaresUniversity of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, USA.
Jongphil KimDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida, USA.
Jing LyuDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Yingmiao LiuDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Andrew B NixonDepartment of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
Dae Won KimDepartment of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Duke Medical Center · USMoffitt Cancer Center · USUniversity of New Mexico · USUniversity of North Carolina at Chapel Hill · USVirginia Commonwealth University · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI John L. Cleveland · 1998 to 2026
$93.5M
Bayer HealthCareH. Lee Moffitt Cancer Center and Research InstituteNCI NIH HHS P30 CA076292NCI NIH HHS P30-CA076292
6 · The paper itself

Abstract

backgroundRegorafenib is an oral multikinase inhibitor targeting angiogenesis, oncogenesis, and cancer proliferation/metastasis. This study evaluated the efficacy of regorafenib in refractory biliary tract cancer (BTC) in a multi-institutional phase 2 study.

methodsPatients with BTC who progressed on at least 1 line of systemic therapy received regorafenib at 160 mg daily for 21 days on and 7 days off. The primary endpoint was 6-month overall survival (OS), and the secondary endpoints were median OS, progression-free survival (PFS), and objective response rates. Pretreatment plasma was collected for cytokine evaluation.

resultsA total of 39 patients were enrolled, and 33 were evaluable for efficacy. The median PFS and OS were 3.7 and 5.4 months, respectively, with survival rates of 46.2% at 6 months, 35.9% at 12 months, and 25.6% at 18 months for the intention-to-treat population. For the 33 evaluable patients who received regorafenib for at least 3 weeks, the median PFS and OS were 3.9 and 6.7 months, respectively, with survival rates of 51.5% at 6 months, 39.4% at 12 months, and 27.3% at 18 months. The objective response rate was 9.1%, and the disease control rate was 63.6%. Twenty-eight patients (71.8%) experienced grade 3/4 adverse events. Among the 23 cytokines analyzed, elevated baseline vascular endothelial growth factor D (VEGF-D) was associated with shorter PFS, whereas elevated baseline interleukin 6 (IL-6) and glycoprotein 130 (GP130) were associated with shorter OS.

conclusionsRegorafenib demonstrated modest clinical efficacy in heavily pretreated patients with BTC. Further exploration of biomarkers is warranted to identify a group of patients with BTC who may benefit from regorafenib.

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsBiliary Tract NeoplasmsCholangiocarcinomaDrug-Related Side Effects and Adverse ReactionsFemaleGene Expression Regulation, NeoplasticHumansMaleMiddle AgedPhenylurea CompoundsProgression-Free SurvivalPyridinesVascular Endothelial Growth Factor DAngiogenesis InhibitorsPhenylurea CompoundsPyridinesregorafenibVascular Endothelial Growth Factor DVEGFD protein, humanbiliary tract cancerchemotherapy-refractorycholangiocarcinomagallbladder cancerregorafenib

Identifiers

PMID32453456
PMCPMC7787270
OpenAlexW3031031837

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.