Evidence map›Paper›PMID 40742049›Full record

Trial reportThe oncologist2025

Carelizumab and rivoceranib for advanced extramammary Paget's disease: an investigator-initiated multicenter, single-arm, phase II trial.

Sheng Zhang, Mengyang Ju, Qin Wang, Dongyuan Zhu, Zengjun Liu, Xiongjun Ye, Wenfeng Li

Abstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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

7 authors.

Sheng ZhangMedical Oncology, Shanghai Cancer Center and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200030, China.ORCID 0000-0002-0109-6951
Mengyang JuMedical Oncology, Shanghai Cancer Center and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200030, China.
Qin WangShanghai University of Engineering Science, Shanghai 201620, China.
Dongyuan ZhuRare Tumors Department, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.
Zengjun LiuRare Tumors Department, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China.
Xiongjun YeDepartment of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Wenfeng LiAffiliated Hospital of Qingdao University, Qingdao 266003, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExtramammary Paget's disease (EMPD) is a rare cancer without standard therapy. We evaluated the safety and efficacy of a combination of the humanized monoclonal antiprogrammed death-1 (PD-1) antibody, carelizumab, with rivoceranib, a vascular endothelial growth factor receptor (VEGFR) inhibitor, in patients with advanced EMPD.

methodsThis multicenter, single-arm, phase II trial included 12 patients with EMPD. The primary endpoint is the objective response rate (ORR), defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria. It is hypothesized that the ORR will be less than 10% if the treatment is ineffective and will reach 35% if effective. Secondary endpoints include progression-free survival (PFS) and safety assessments. Eligible patients are aged ≥18 years, with histologically confirmed advanced EMPD. Treatment consists of carelizumab (200 mg intravenously every 3 weeks) and rivoceranib (250 mg orally once daily), with dose adjustments permitted based on toxicity profiles.

resultsBetween June 2024 and February 2025, 12 patients were enrolled. One patient withdrew from the trial because of nontreatment-related accidents, and a total of 11 patients completed at least 1 cycle of treatment. The median PFS is 2.4 months (95% CI, 2.1-4.4 months). Among these 11 patients, no patients achieved CR or PR. Six patients (50%) experienced grade 3 adverse events.

conclusionsThis is the first trial evaluating the combination of a PD-1 inhibitor and a VEGFR inhibitor in advanced EMPD. This combination therapy is well tolerated but does not appear to have clinically meaningful activity in advanced EMPD. This trial was registered at the Chinese Clinical Trial number registration: 2400086153.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsPaget Disease, ExtramammaryAgedAged, 80 and overClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, Humanizedcamrelizumabcarelizumabclinical trialextramammary Paget’s diseaserivoceranib

Identifiers

PMID40742049
PMCPMC12311928

What OpenQuestion holds

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Registered trials

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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.