Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- ultrasonic microbubbles
- Conditions
- Gastrointestinal Neoplasms
- Sponsor
- Peking University Cancer Hospital & Institute
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of Participants with Serious and Non-Serious Adverse Events
- Last Updated
- 10 years ago
Overview
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)
Investigators
Kun Yan
chief director
Peking University Cancer Hospital & Institute
Eligibility Criteria
Inclusion Criteria
- •Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
- •Failed routine chemotherapy
- •Neoplasms can be evaluated by imaging
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
Arms & Interventions
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.
Intervention: ultrasonic microbubbles
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.
Intervention: platinum and gemcitabine
Outcomes
Primary Outcomes
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: 1 month
Secondary Outcomes
- Time to Disease Progression(one year)