Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System
Conditions
Gastrointestinal Neoplasms
Conditions: official terms
Digestive System Neoplasms - Gastrointestinal Neoplasms - Neoplasms
Conditions: Keywords
microbubble, chemotherapy, alimentary
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ultrasonic microbubbles Type: Device
Name: platinum and gemcitabine Type: Drug
Overall Status
Recruiting
Summary
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
Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.

1. Main purpose

1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.

2. Secondary purpose

1. To observe tumor clinical benefit rate (CR+PR+SD).

2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Beijing Cancer Hospital
Beijing, China
Status: Recruiting
Contact: Wei Yang, Doctor - 0086-10-88196195 - 13681408183@163.com
Start Date
October 2014
Completion Date
June 2016
Sponsors
Beijing Cancer Hospital
Source
Beijing Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page