NCT02233205

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Gastrointestinal Neoplasms

Interventions

Type	Name	Description
DEVICE	ultrasonic microbubbles	inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
DRUG	platinum and gemcitabine	Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2014-09-08
• Last updated: 2015-07-24

Locations

1 site across 1 country: China