Evidence map›Paper›PMID 38325225›Full record

ArticleESMO open2024

The combination treatment of oncolytic adenovirus H101 with nivolumab for refractory advanced hepatocellular carcinoma: an open-label, single-arm, pilot study.

L Yi, Z Ning, L Xu, Y Shen, X Zhu, W Yu, J Xie, Z Meng

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06685354 (Sequential Targeted and Immunotherapy With Recombined Human Type 5 Adenovirus Via Hepatic Arterial Infusion for BCLC Stage C Hepatocellular Carcinoma), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
14.3field-weighted citation impact, top 1% 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.

NCT06685354 phase2not yet recruitingnot on this map

Sequential Targeted and Immunotherapy With Recombined Human Type 5 Adenovirus Via Hepatic Arterial Infusion for BCLC Stage C Hepatocellular Carcinoma: A Prospective Single-Center Single-Arm Pilot Study

TypeinterventionalSponsorHenan Cancer HospitalRan2024 to 2026Enrolled11ConditionsHepatocellular Carcinoma (HCC)Armshepatic arterial infusion of recombinant human type 5 adenovirus
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
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  15. Oncolytic Virotherapy in Solid Tumors: A Current Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
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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

8 authors at 2 institutions in 1 country.

L YiDepartment of Integrative Oncology, Shanghai, China; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Z NingDepartment of Integrative Oncology, Shanghai, China; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
L XuDepartment of Integrative Oncology, Shanghai, China; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Y ShenDepartment of Integrative Oncology, Shanghai, China; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
X ZhuDepartment of Integrative Oncology, Shanghai, China; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
W YuDepartment of Integrative Oncology, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Shanghai Key Laboratory of Medical Epigenetics, Institutes of Biomedical Sciences, Fudan University, Shanghai, China.
J XieDepartment of Integrative Oncology, Shanghai, China; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China; Shanghai Key Laboratory of Medical Epigenetics, Institutes of Biomedical Sciences, Fudan University, Shanghai, China. Electronic address: isable624@163.com.
Z MengDepartment of Integrative Oncology, Shanghai, China; Department of Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: mengshca@fudan.edu.cn.
Shanghai Medical College of Fudan University · CNFudan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundH101, an innovative oncolytic adenovirus, has shown potential in modifying the tumor microenvironment from immunologically 'cold' to 'hot'. When combined with nivolumab, a programmed cell death protein 1 inhibitor, this synergy may offer substantial therapeutic benefits beyond the capabilities of each agent alone. PATIENTS AND

methodsIn this pilot study, we assessed the efficacy and safety of combining H101 with nivolumab in advanced hepatocellular carcinoma (HCC) patients who failed prior systemic therapy. The participants received initial oncolytic virus (OV) pretreatment with intratumoral H101 injections (5.0 × 10

resultsBetween March 2020 and March 2022, 18 of 21 screened patients were assessable, showing an ORR of 11.1% [two cases of partial response (PR) and five cases of stable disease], with extrahepatic injections often leading to favorable outcomes. The disease control rate stood at 38.9%, with a 6-month survival rate of 88.9%. Median progression-free survival was 2.69 months, and overall survival (OS) was 15.04 months. Common adverse events included low-grade fever (100%) and pain related to centesis (33.3%), and no grade 3/4 events were reported. Significantly, local H101 injection showed potential in reversing immune checkpoint inhibitor resistance, evidenced by over 2.5 years of extended OS in PR cases with low α-fetoprotein. Additionally, decreasing neutrophil-to-lymphocyte ratio during OV pretreatment may predict positive outcomes.

conclusionsThis study demonstrates the potential efficacy of combining H101 with nivolumab in treating refractory advanced HCC, with well-tolerated toxicities.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsAdenoviridaeHumansNivolumabPilot ProjectsTumor MicroenvironmentNivolumabadvanced hepatocellular carcinomanivolumaboncolytic adenovirusviral immunotherapy

Identifiers

PMID38325225
PMCPMC10937204
OpenAlexW4391557605

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.