Evidence map›Paper›PMID 36152015›Full record

Trial reportHepatology (Baltimore, Md.)2023

Silmitasertib plus gemcitabine and cisplatin first-line therapy in locally advanced/metastatic cholangiocarcinoma: A Phase 1b/2 study.

Mitesh J Borad, Li-Yuan Bai, Donald Richards, Kabir Mody, Joleen Hubbard, Sun Young Rha, John Soong, Daniel McCormick, Emmett Tse, Daniel O'Brien and 5 more

Open access · greenAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. A Novel Dysferlin-Binding Kinase CK2α Promotes Plasma Membrane Repair in Dysferlinopathy.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Article
  5. Article
  6. Article
  7. Pro-Apoptotic Activity of 1-(4,5,6,7-Tetrabromo-1International journal of molecular sciences · 2025
    Article
  8. Review
  9. Article
  10. CK2B Induces CD8Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 3 countries.

Mitesh J BoradCenter for Individualized Medicine, Liver and Biliary Cancer Research Program and Cancer Cell , Gene and Virus Therapy Lab, Mayo Clinic Arizona , Scottsdale , Arizona , USA.
Li-Yuan BaiChina Medical University Hospital, and China Medical University , Taichung , Taiwan.
Donald RichardsTexas Oncology-Tyler, US Oncology Research , Tyler , Texas , USA.
Kabir ModyDivision of Hematology and Oncology , Mayo Clinic Jacksonville , Jacksonville , Florida , USA.
Joleen HubbardDepartment of Medical Oncology , Mayo Clinic Rochester , Rochester , Minnesota , USA.
Sun Young RhaYonsei Cancer Center , Yonsei University College of Medicine , Seoul , South Korea.
John SoongClinical Operations , Senhwa Biosciences Corporation , San Diego , California , USA.
Daniel McCormickClinical Operations , Senhwa Biosciences Corporation , San Diego , California , USA.
Emmett TseClinical Operations , Senhwa Biosciences Corporation , San Diego , California , USA.
Daniel O'BrienDepartment of Quantitative Health Sciences , Mayo Clinic , Rochester , Minnesota , USA.
Ahmad BayatRegulatory Affairs , Amarex Clinical Research , Germantown , Maryland , USA.
Daniel AhnDivision of Hematology/Medical Oncology, Department of Internal Medicine , Mayo Clinic Arizona , Phoenix , Arizona , USA.
S Lindsey DavisDivision of Medical Oncology , University of Colorado Cancer Center , Aurora , Colorado , USA.
Joon Oh ParkDivision of Hematology-Oncology , Samsung Medical Centre, Sungkyunkwan University School of Medicine , Seoul , South Korea.
Do-Youn OhCancer Research Institute , Seoul National University Hospital, Seoul National University College of Medicine, Integrated Major in Innovative Medical Science, Seoul National University Graduate School , Seoul , South Korea.
Mayo Clinic in Florida · USChina Medical University Hospital · TWMayo Clinic · USMayo Clinic in Arizona · USSeoul National University Hospital · KRSungkyunkwan University · KRTexas Oncology · USUniversity of Colorado Cancer Center · USYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsThis study aimed to investigate safety and efficacy of silmitasertib, an oral small molecule casein kinase 2 inhibitor, plus gemcitabine and cisplatin (G+C) versus G+C in locally advanced/metastatic cholangiocarcinoma. APPROACH AND

resultsThis work is a Phase 1b/2 study (S4-13-001). In Phase 2, patients received silmitasertib 1000 mg twice daily for 10 days with G+C on Days 1 and 8 of a 21-day cycle. Primary efficacy endpoint was progression-free survival (PFS) in the modified intent-to-treat population (defined as patients who completed at least one cycle of silmitasertib without dose interruption/reduction) from both phases (silmitasertib/G+C n = 55, G+C n = 29). The response was assessed by Response Evaluation Criteria in Solid Tumors v1.1. The median PFS was 11.2 months (95% confidence interval [CI], 7.6, 14.7) versus 5.8 months (95% CI, 3.1, not evaluable [NE]) ( p  = 0.0496); 10-month PFS was 56.1% (95% CI, 38.8%, 70.2%) versus 22.2% (95% CI, 1.8%, 56.7%); and median overall survival was 17.4 months (95% CI, 13.4, 25.7) versus 14.9 months (95% CI, 9.9, NE) with silmitasertib/G+C versus G+C. Overall response rate was 34.0% versus 30.8%; the disease control rate was 86.0% versus 88.5% with silmitasertib/G+C versus G+C. Almost all silmitasertib/G+C (99%) and G+C (93%) patients reported at least one treatment emergent adverse event (TEAE). The most common TEAEs (all grades) with silmitasertib/G+C versus G+C were diarrhea (70% versus 13%), nausea (59% vs. 30%), fatigue (47% vs. 47%), vomiting (39% vs. 7%), and anemia (39% vs. 30%). Twelve patients (10%) discontinued treatment because of TEAEs during the study.

conclusionsSilmitasertib/G+C demonstrated promising preliminary evidence of efficacy for the first-line treatment of patients with locally advanced/metastatic cholangiocarcinoma.

Indexed as

Bile Duct NeoplasmsCholangiocarcinomaAntineoplastic Combined Chemotherapy ProtocolsBile Ducts, IntrahepaticCisplatinDeoxycytidineGemcitabineHumansNaphthyridinesPhenazinesCisplatinDeoxycytidineGemcitabineNaphthyridinesPhenazinessilmitasertib

Identifiers

PMID36152015
OpenAlexW4296940612

What OpenQuestion holds

Textmetadata
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.