Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02233205|
Recruitment Status : Unknown
Verified July 2015 by Kun Yan, Beijing Cancer Hospital.
Recruitment status was: Recruiting
First Posted : September 8, 2014
Last Update Posted : July 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Neoplasms||Device: ultrasonic microbubbles Drug: platinum and gemcitabine||Phase 1 Phase 2|
Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.
- 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.
- To observe tumor clinical benefit rate (CR+PR+SD).
- To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
Experimental: microbubbles & platinum and gemcitabine
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
inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
Other Name: Sonovue
Drug: platinum and gemcitabine
Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 1 month ]
- Time to Disease Progression [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233205
|Contact: Yang Wei, Doctoremail@example.com|
|Contact: Yanjie Wang, Doctorfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, China, 100142|
|Contact: Wei Yang, Doctor 0086-10-88196195 email@example.com|
|Contact: Yanjie Wang, Doctor 0086-10-88196941 firstname.lastname@example.org|
|Sub-Investigator: Yan Li, Doctor|
|Sub-Investigator: Wei Yang, Doctor|
|Sub-Investigator: Jifang Gong, Doctor|
|Principal Investigator:||Kun Yan, Master||Beijing Cancer Hospital|
|Principal Investigator:||Lin Shen, Doctor||Beijing Cancer Hospital|