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

Phase 1

• Conditions: Gastrointestinal Neoplasms
• Interventions: Device: ultrasonic microbubbles; Drug: platinum and gemcitabine

• Registration Number: NCT02233205
• Lead Sponsor: Peking University Cancer Hospital & Institute

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)

Study Timeline

• Study First Submitted: 2014-08-31
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-08
• Study Start: 2014-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microbubbles & platinum and gemcitabine	ultrasonic microbubbles	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.
microbubbles & platinum and gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious and Non-Serious Adverse Events	1 month

Secondary Outcome Measures

Name	Time	Method
Time to Disease Progression	one year

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China