Trial reportHuman gene therapy2010
Phase I/II study of oncolytic herpes simplex virus NV1020 in patients with extensively pretreated refractory colorectal cancer metastatic to the liver.
Trial report in Human gene therapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
98 citing papers in PubMed, 2 syntheses or guidelines pooled it, 161 citations in OpenAlex.
- Pooled it
- Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020Pooled it
- Preliminary efficacy and safety of YSCH-01 in patients with advanced solid tumors: an investigator-initiated trial.Journal for immunotherapy of cancer · 2024Trial
- Intratumoral OH2, an oncolytic herpes simplex virus 2, in patients with advanced solid tumors: a multicenter, phase I/II clinical trial.Journal for immunotherapy of cancer · 2021Trial
- Human Trial of a Genetically Modified Herpes Simplex Virus for Rapid Detection of Positive Peritoneal Cytology in the Staging of Pancreatic Cancer.EBioMedicine · 2016Trial
- Clinical Progress in Virotherapy: Application and Future Prospects in Head and Neck Cancer.International journal of molecular sciences · 2026Review
- Advances in oncolytic viruses immunotherapy of hepatocellular carcinoma.Discover oncology · 2026Review
- Oncolytic viruses and cytokine-based gene therapies reprogram the tumor microenvironment.Nature cancer · 2026Review
- Engineering HSV-1 for oncolytic therapy: From molecular entry mechanisms to retargeting strategies.Genes & diseases · 2026Review
- Tackling cancer heterogeneity with systemically delivered oncolytic adenoviruses transcriptionally targeted with hybrid promoters.Molecular therapy. Oncology · 2025Article
- Functions and clinical implications of the liver microenvironment in hepatic uveal melanoma metastases.Cancer metastasis reviews · 2025Review
- Review
- Viral-Directed Augmentation of Kupffer Cell Cross-Presentation Provokes Antitumor Immunity Against Liver Metastasis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Advances in the Drug Development and Quality Evaluation Principles of Oncolytic Herpes Simplex Virus.Viruses · 2025Review
- Mesenchymal stem cell origin contributes to the antitumor effect of oncolytic virus carriers.Molecular therapy. Oncology · 2024Article
- 4-1BBL-Armed Oncolytic Herpes Simplex Virus Exerts Antitumor Effects in Pancreatic Ductal Adenocarcinoma.Vaccines · 2024Article
- Safety of non-replicative and oncolytic replication-selective HSV vectors.Trends in molecular medicine · 2024Review
- Cytokine-armed oncolytic herpes simplex viruses: a game-changer in cancer immunotherapy?Journal for immunotherapy of cancer · 2024Review
- Stage IV Colorectal Cancer at Initial Presentation versus Progression during and after Treatment, Differences in Management: Management Differences for Initial Presentation versus Progression of Disease after Initial Treatment.Clinics in colon and rectal surgery · 2024Review
- The Future of Interventions for Stage IV Colorectal Cancers.Clinics in colon and rectal surgery · 2024Review
38 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 2 countries.
Funding
Abstract
This multicenter phase I/II study evaluated the safety, pharmacokinetics, and antitumor effects of repeated doses of NV1020, a genetically engineered oncolytic herpes simplex virus, in patients with advanced metastatic colorectal cancer (mCRC). Patients with liver-dominant mCRC received four fixed NV1020 doses via weekly hepatic artery infusion, followed by two or more cycles of conventional chemotherapy. Phase I included cohorts receiving 3 × 10(6), 1 × 10(7), 3 × 10(7), and 1 × 10(8) plaque-forming units (PFU)/dose to determine the optimal biological dose (OBD) for phase II. Blind independent computed tomography scan review was based on RECIST (response evaluation criteria in solid tumors) to assess hepatic tumor response. Phase I and II enrolled 13 and 19 patients, respectively. Patients experienced transient mild-moderate febrile reactions after each NV1020 infusion. Grade 3/4 virus-related toxicity was limited to transient lymphopenia in two patients. NV1020 shedding was not detected. Simultaneous cytokine and grade 1 coagulation perturbations were dose-limiting at 1 × 10(8) PFU/dose, considered the OBD. All 22 OBD patients had previously received 5-fluorouracil; most had received oxaliplatin or irinotecan (50% had both), many with at least one targeted agent. After NV1020 administration, 50% showed stable disease. The best overall tumor control rate after chemotherapy was 68% (1 partial response, 14 stable disease); this did not correlate with baseline variables or chemotherapy. Median time to progression was 6.4 months (95% confidence interval: 2, 8.9); median overall survival was 11.8 months (95% confidence interval: 8.3, 20.7). One-year survival was 47.2%. We conclude that NV1020 stabilizes liver metastases with minimal toxicity in mCRC. It may resensitize metastases to salvage chemotherapy and extend overall survival. A randomized phase II/III trial now appears justified.
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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.