Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

Study Overview
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Brief Summary
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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.

Detailed Description
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Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. Main purpose To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma. To explore the largest mechanical index and ultrasonic treatment time which patients can endure. Secondary purpose To observe tumor clinical benefit rate (CR+PR+SD). To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

Official Title
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Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma

Conditions
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Gastrointestinal Neoplasms

Intervention / Treatment
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* Device: ultrasonic microbubbles
* Drug: platinum and gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microbubbles & platinum and gemcitabine<br>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. | Device: ultrasonic microbubbles<br>* inject 1ml once and five times in 20min, locate the probe on the lesion at the same time<br>* Other names: Sonovue;Drug: platinum and gemcitabine<br>* Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious and Non-Serious Adverse Events |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbubble, chemotherapy, alimentary