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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02233205

Enrollment

Registered

2014-09-08

Start date

2014-10-31

Completion date

2016-06-30

Last updated

2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasms

Keywords

microbubble, chemotherapy, alimentary

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)

Interventions

DEVICEultrasonic microbubbles

inject 1ml once and five times in 20min, locate the probe on the lesion at the same time

DRUGplatinum and gemcitabine

Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Serious and Non-Serious Adverse Events	1 month

Secondary

Measure	Time frame
Time to Disease Progression	one year

Countries

China

Contacts

Primary ContactYang Wei, Doctor

13681408183@163.com0086-10-88196195

Backup ContactYanjie Wang, Doctor

philinsss@163.com0086-10-88196941

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026