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

Peking University Cancer Hospital & Institute

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Gastrointestinal Neoplasms

Treatments: Device: ultrasonic microbubbles; Drug: platinum and gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02233205

2014YJZ11

Details and patient eligibility

About

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.

Full 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)

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

microbubbles & platinum and gemcitabine

Experimental group

Description:

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.

Treatment:

Drug: platinum and gemcitabine

Device: ultrasonic microbubbles