Evidence map›Paper›PMID 40140696›Full record

ArticleBritish journal of cancer2025

A phase 1 study to assess the safety, tolerability and effectiveness of PV-10 (Rose Bengal Sodium) in neuroendocrine tumours metastatic to the liver.

Timothy Price, Laura Depauw, Gabrielle Cehic, Eric Wachter, Ruben Sebben, Jessica Reid, Susan Neuhaus, Anas Alawawdeh, Ian D Kirkwood, Rahul Solanki and 4 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in British journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02693067 (A Phase 1 Study to Assess the Safety, Tolerability and Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumours), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT02693067 phase1unknown statusnot on this map

A Phase 1 Study to Assess the Safety, Tolerability and Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver in the Reduction of Biochemical Markers and Symptoms Caused by Secretory Products

TypeinterventionalSponsorProvectus Biopharmaceuticals, Inc.Ran2016 to 2023Enrolled12ConditionsNeuroendocrine Tumors Metastatic to the LiverArmsRose bengal disodium
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

14 authors.

Timothy Price *The Queen Elizabeth Hospital, Woodville, SA, Australia. timothy.price@sa.gov.au.ORCID http://orcid.org/0000-0002-3922-2693
Laura Depauw *The Queen Elizabeth Hospital, Woodville, SA, Australia.ORCID http://orcid.org/0000-0002-4183-6395
Gabrielle CehicThe Queen Elizabeth Hospital, Woodville, SA, Australia.ORCID http://orcid.org/0000-0002-7212-9386
Eric WachterProvectus Biopharmaceuticals, Inc, Knoxville, TN, USA.
Ruben SebbenThe Queen Elizabeth Hospital, Woodville, SA, Australia.
Jessica ReidThe Queen Elizabeth Hospital, Woodville, SA, Australia.
Susan NeuhausUniversity of Adelaide, Adelaide, SA, Australia.
Anas AlawawdehThe Queen Elizabeth Hospital, Woodville, SA, Australia.ORCID http://orcid.org/0000-0002-1629-9225
Ian D KirkwoodUniversity of Adelaide, Adelaide, SA, Australia.
Rahul SolankiRoyal Adelaide Hospital, Adelaide, SA, Australia.
Mark McGregorThe Queen Elizabeth Hospital, Woodville, SA, Australia.ORCID http://orcid.org/0000-0001-9397-5808
Lisa LeopardiThe Queen Elizabeth Hospital, Woodville, SA, Australia.
Dominic RodriguesProvectus Biopharmaceuticals, Inc, Knoxville, TN, USA.
Guy MaddernThe Queen Elizabeth Hospital, Woodville, SA, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetastatic neuroendocrine neoplasms (mNEN) require new treatment options. Intralesional (IL) PV-10 is an autolytic chemotherapy that may elicit an adaptive immune response.

methodsThis phase 1 study evaluated IL PV-10 administered percutaneously to hepatic lesions in patients with progressive mNEN. IL PV-10 was injected in a single lesion per treatment cycle. A treatment cycle could be repeated after ≥ 6 weeks if multiple targetable lesions were present. The primary endpoint was safety.

resultsTwelve patients were enrolled with a median age of 66 years (range 47-79). All patients had progressive disease at enrolment and received prior somatostatin analogues; 10 patients had peptide receptor radionuclide therapy (PRRT) treatment. One lesion was injected per cycle for all 12 patients. Reported grade 3 side effects were photosensitivity (1 patient), face oedema (1 patient), elevated transaminases (1 patient), hypertension (2 patients). Response rate was 42% of injected lesions with patient-level disease control of 84%, PFS 9.4 months and median OS 24.0 months.

conclusionsIL PV-10 elicited no safety concerns. Encouraging evidence of local and systemic disease control was seen in a heavily pre-treated, progressing mNEN population. CLINICAL TRIAL REGISTRATION NUMBER: NCT02693067.

Indexed as

Liver NeoplasmsNeuroendocrine TumorsAgedFemaleHumansMaleMiddle AgedTreatment Outcome

Identifiers

PMID40140696
PMCPMC12081874

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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.