Evidence map›Paper›PMID 38689424›Full record

Trial reportClinical and translational medicine2024

Bortezomib in previously treated phosphatase and tension homology-deficient patients with advanced intrahepatic cholangiocarcinoma: An open-label, prospective and single-centre phase II trial.

Tian-Mei Zeng, Tian-Yi Jiang, Guang Yang, Zhuo Cheng, Cheng Lou, Wei Wei, Chen-Jie Tao, Shouzi Hu, Hui Wang, Xiao-Wen Cui and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and translational medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07715903 (Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.9field-weighted citation impact, top 10% 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.

NCT07715903 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2026 to 2031Enrolled20ConditionsColorectal Neoplasms, Neoplasms, Intrahepatic Cholangiocarcinoma, Adrenocortical CarcinomaArmsCarfilzomib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Proteasome: Role in T Cell Function Regulation.International journal of biological sciences · 2025
    Review
  4. Review
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

14 authors at 2 institutions in 1 country.

Tian-Mei ZengDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Tian-Yi JiangNational Center for Liver Cancer, The Naval Medical University, Shanghai, China.
Guang YangDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Zhuo ChengDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Cheng LouDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Wei WeiDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Chen-Jie TaoDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Shouzi HuDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Hui WangDepartment of Hepatobiliary Diseases, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.
Xiao-Wen CuiNational Center for Liver Cancer, The Naval Medical University, Shanghai, China.
Ye-Xiong TanNational Center for Liver Cancer, The Naval Medical University, Shanghai, China.
Li-Wei DongNational Center for Liver Cancer, The Naval Medical University, Shanghai, China.
Hong-Yang WangDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.ORCID 0000-0002-4709-3334
Zhen-Gang YuanDepartment of Oncology, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai, China.ORCID 0000-0003-4031-8606
Second Military Medical University · CNNaval University of Engineering · CN

Funding

Clinical Research Plan of Shanghai Hospital Development Center SHDC12019X04Clinical Research Plan of Shanghai Hospital Development Center SHDC2020CR2011Akey technologies Research and Development Program of China 2022YFC2503704National Natural Science Foundation of China 32270814National Natural Science Foundation of China 81988101National Natural Science Foundation of China 82172895National Natural Science Foundation of China 91859205Shanghai Sailing Program 21YF1457900
6 · The paper itself

Abstract

introductionIntrahepatic cholangiocarcinoma (ICC) is characterized by a dismal prognosis with limited therapeutic alternatives. To explore phosphatase and tension homolog (PTEN) as a biomarker for proteasome inhibition in ICC, we conducted a phase II trial to assess the second-line efficacy of bortezomib in PTEN-deficient advanced ICC patients.

methodsA total of 130 patients with advanced ICC in our centre were screened by PTEN immunohistochemical staining between 1 July 2017, and 31 December 2021, and 16 patients were ultimately enrolled and treated with single-agent bortezomib 1.3 mg/m

resultsThe median follow-up was 6.55 months (95% confidence interval [CI]: 0.7-19.9 months). Among the 16 enrolled patients, the ORR was 18.75% (3/16) and the disease control rate was 43.75% (7/16). The median progress-free survival was 2.95 months (95% CI: 2.1-5.1 months) and the median overall survival (mOS) was 7.2 months (95% CI: 0.7-21.6 months) in the intent-to-treat-patients. Treatment-related adverse events of any grade were reported in 16 patients, with thrombopenia being the most common toxicity. Patients with PTEN staining scores of 0 were more likely to benefit from bortezomib than those with staining scores > 0.

conclusionsBortezomib yielded an encouraging objective response and a favourable OS as a second-line agent in PTEN-deficient ICC patients. Our findings suggest bortezomib as a promising therapeutic option for patients with PTEN-deficient ICC. HIGHLIGHTS: There is a limited strategy for the second-line option of intrahepatic cholangiocarcinoma (ICC). This investigator-initiated phase 2 study evaluated bortezomib in ICC patients with phosphatase and tension homology deficiency. The overall response rate was 18.75% and the overall survival was 7.2 months in the intent-to-treat cohort. These results justify further developing bortezomib in ICC patients with PTEN deficiency.

Indexed as

Bile Duct NeoplasmsBortezomibCholangiocarcinomaPTEN PhosphohydrolaseAdultAgedAntineoplastic AgentsFemaleHumansMaleMiddle AgedProspective StudiesAntineoplastic AgentsBortezomibPTEN PhosphohydrolasePTEN protein, humanbortezomibintrahepatic cholangiocarcinomaPTEN

Identifiers

PMID38689424
PMCPMC11061377
OpenAlexW4396560270

What OpenQuestion holds

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LicenceCC BY
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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.