Trial reportEuropean radiology2024
Clinical sonochemotherapy of inoperable pancreatic cancer using diagnostic ultrasound and microbubbles: a multicentre, open-label, randomised, controlled trial.
Trial report in European radiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07314385 (A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis), which is not on this map. Cited by 8 papers.
What it found
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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.
A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis
Who cites it
8 citing papers in PubMed.
- Sonocavitation therapy for pancreatic cancer: Research progress, clinical application and future perspectives.iScience · 2026Review
- Clinical translation and landscape of stimuli-responsive nanomedicines and microscale therapeutics.Chemical Society reviews · 2026Review
- Ultrasound-mediated targeted micro/nanobubbles: breaking new boundaries in precision tumor therapy.International journal of surgery (London, England) · 2026Article
- Ultrasound-Stimulated microbubble cavitation improved tumor perfusion and promoted tumor vascular normalization in a rabbit VX2 tumor model.Medical oncology (Northwood, London, England) · 2025Article
- Ultrasound-responsive micro/nanobubbles based intelligent theranostic systems for precision tumor therapy.Journal of nanobiotechnology · 2025Review
- A Review on the Structure-Response-Efficacy Optimization of Ultrasound-Responsive Micro/Nanobubbles for Cancer Therapy.Pharmaceutics · 2025Review
- Influence of cell shape on sonoporation efficiency in microbubble-facilitated delivery using micropatterned cell arrays.Scientific reports · 2024Article
- Article
Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
objectivesSonochemotherapy, which uses microbubble (MB)-assisted ultrasound (US) to deliver chemotherapeutic agents, has the potential to enhance tumour chemotherapy. The combination of US and MB has been demonstrated to prolong the survival of patients with pancreatic cancer. This phase 2 clinical trial aimed to determine the clinical efficacy and safety of sonochemotherapy for inoperable pancreatic ductal adenocarcinoma by using US and MB.
methodsEighty-two patients with stage III or IV pancreatic cancer were recruited from July 2018 to March 2021 and followed up until September 2022. US treatment was performed with a modified diagnostic US scanner for 30 min after chemotherapeutic infusion. The primary endpoint was overall survival (OS), and the secondary endpoints were Eastern Cooperative Oncology Group (ECOG) status < 2, progression-free survival (PFS), disease control rate (DCR), and adverse events.
resultsSeventy-eight patients were randomly allocated (40 to chemotherapy and 38 to sonochemotherapy). The median OS was longer with sonochemotherapy than with chemotherapy (9.10 vs. 6.10 months; p = 0.037). The median PFS with sonochemotherapy was 5.50 months, compared with 3.50 months (p = 0.080) for chemotherapy. The time of ECOG status < 2 was longer with sonochemotherapy (7.20 months) than with chemotherapy (5.00 months; p = 0.029). The DCR was 73.68% for sonochemotherapy compared with 42.50% for the control (p = 0.005). The incidence of overall adverse events was balanced between the two groups.
conclusionsThe use of sonochemotherapy can extend the survival and well-being time of stage III or IV pancreatic cancer patients without any increase in serious adverse events.
trial registrationChineseClinicalTrials.gov ChiCTR2100044721 CLINICAL RELEVANCE STATEMENT: This multicentre, randomised, controlled trial has proven that sonochemotherapy, namely, the combination of diagnostic ultrasound, microbubbles, and chemotherapy, could extend the overall survival of patients with end-stage pancreatic ductal adenocarcinoma from 6.10 to 9.10 months without increasing any serious adverse events. KEY POINTS: • This is the first multicentre, randomised, controlled trial of sonochemotherapy for clinical pancreatic cancer treatment using ultrasound and a commercial ultrasound contrast agent. • Sonochemotherapy extended the median overall survival from 6.10 (chemotherapy alone) to 9.10 months. • The disease control rate increased from 42.50% with chemotherapy to 73.68% with sonochemotherapy.
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Identifiers
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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.