Evidence map›Paper›PMID 34696309›Full record

ArticleVaccines2021

Case Report: Marked Survival Advantage of Two Colorectal Cancer Patients with Liver Metastases Treated with Vigil and FOLFOX-6.

Vedin Barve, Ned Adams, Laura Stanbery, Luisa Manning, Staci Horvath, Gladice Wallraven, Ernest Bognar, Minal Barve, John Nemunaitis

Registry-linked trialOpen access · goldAbstract readCase Reports
In one paragraph

Article in Vaccines, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01505166 (Randomized Phase II Trial of Post-operative Adjuvant Chemotherapy ± FANG™ Autologous Tumor Cell Vaccine in Colorectal Carcinoma With Liver Metastases), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 31% 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.

NCT01505166 phase2terminatednot on this map

Randomized Phase II Trial of Post-operative Adjuvant Chemotherapy ± FANG™ Autologous Tumor Cell Vaccine in Colorectal Carcinoma With Liver Metastases

TypeinterventionalSponsorGradalis, Inc.Ran2012 to 2016Enrolled3ConditionsColon CancerArmsVigil™ Vaccine, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

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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 3 institutions in 1 country.

Vedin BarveTexas Oncology Physician Association, Dallas, TX 75251, USA.ORCID 0000-0002-7966-2247
Ned AdamsMary Crowley Cancer Research, Dallas, TX 75230, USA.
Laura StanberyGradalis, Inc., Carrollton, TX 75006, USA.
Luisa ManningGradalis, Inc., Carrollton, TX 75006, USA.
Staci HorvathGradalis, Inc., Carrollton, TX 75006, USA.
Gladice WallravenGradalis, Inc., Carrollton, TX 75006, USA.ORCID 0000-0002-2145-3565
Ernest BognarGradalis, Inc., Carrollton, TX 75006, USA.
Minal BarveTexas Oncology Physician Association, Dallas, TX 75251, USA.
John NemunaitisGradalis, Inc., Carrollton, TX 75006, USA.
Gradalis (United States) · USTexas Oncology · USMary Crowley Cancer Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Colorectal cancer is the third most diagnosed cancer in the United States. Five-year survival rates remain low and many patients will develop liver metastasis. Vigil is an immunotherapy manufactured from autologous tumor cells and transfected ex vivo with a plasmid that encodes the GM-CSF gene and bifunctional shRNA construct to knockdown furin. Here, we report two patients with colorectal cancer and resectable liver metastasis entered into a clinical trial involving Vigil in combination with standard of care modified FOLFOX-6 chemotherapy. The first dose of Vigil was given two weeks before the modified FOLFOX-6 regimen. Vigil treatment continued until Vigil supply was exhausted. Both patients exhibited remarkable response to combination therapy, demonstrating no evidence of disease recurrence for over eight years. Additionally, both patients demonstrated systemic immune response to Vigil therapy as tested by ELISPOT.

Indexed as

colorectal cancerimmunotherapyliver metastases

Identifiers

PMID34696309
PMCPMC8539810
OpenAlexW3207349466

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.