Clinical trial · Interventional
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma
NCT02233205CI-TRIAL-00018644unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| platinum and gemcitabine | Drug | — | UNRESOLVED |
| ultrasonic microbubbles | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- microbubbles & platinum and gemcitabine
- description
- In 30min after chemotherapy, inject ultrasonic microbubbles 1 ml once and inject 5 times in 20min and locate the ultrasonic probe on the lesion The chemotherapy of pancreatic is gemcitabine.The chemotherapy of liver metastases is oxaliplatin with taxol.
- interventionNames
- Device: ultrasonic microbubbles
- Drug: platinum and gemcitabine
Primary outcomes (1)
- measure
- Number of Participants with Serious and Non-Serious Adverse Events
- timeFrame
- 1 month
Secondary outcomes (1)
- measure
- Time to Disease Progression
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma * Failed routine chemotherapy * Neoplasms can be evaluated by imaging * ECOG《2 Exclusion Criteria: * Have systematic chemotherapy in 2 weeks * Be allergic to ultrasonic microbubbles and chemotherapeutics * Uncontrolled high blood pressure, cardiovascular disease * Active bleeding * Have serious mental and psychological disease
References
Publications (4)
- RESULTKotopoulis S, Dimcevski G, Gilja OH, Hoem D, Postema M. Treatment of human pancreatic cancer using combined ultrasound, microbubbles, and gemcitabine: a clinical case study. Med Phys. 2013 Jul;40(7):072902. doi: 10.1118/1.4808149. PMID 23822453
- RESULTDewitte H, Van Lint S, Heirman C, Thielemans K, De Smedt SC, Breckpot K, Lentacker I. The potential of antigen and TriMix sonoporation using mRNA-loaded microbubbles for ultrasound-triggered cancer immunotherapy. J Control Release. 2014 Nov 28;194:28-36. doi: 10.1016/j.jconrel.2014.08.011. Epub 2014 Aug 22. PMID 25151979
- RESULTFan Z, Kumon RE, Deng CX. Mechanisms of microbubble-facilitated sonoporation for drug and gene delivery. Ther Deliv. 2014 Apr;5(4):467-86. doi: 10.4155/tde.14.10. No abstract available. PMID 24856171
- RESULTFeichtinger GA, Hofmann AT, Slezak P, Schuetzenberger S, Kaipel M, Schwartz E, Neef A, Nomikou N, Nau T, van Griensven M, McHale AP, Redl H. Sonoporation increases therapeutic efficacy of inducible and constitutive BMP2/7 in vivo gene delivery. Hum Gene Ther Methods. 2014 Feb;25(1):57-71. doi: 10.1089/hgtb.2013.113. Epub 2013 Nov 27. PMID 24164605