Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-09 @ 11:35 PM
Study NCT ID:
NCT02233205
Status:
UNKNOWN
Last Update Posted:
2015-07-24
First Post:
2014-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System
Sponsor:
Peking University Cancer Hospital & Institute
Organization:
Study Overview
Official Title:
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: