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

July 23, 2015 updated by: Kun Yan, Peking University Cancer Hospital & Institute

Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yan Li, Doctor
        • Sub-Investigator:
          • Wei Yang, Doctor
        • Sub-Investigator:
          • Jifang Gong, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: ultrasonic microbubbles
inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
Other Names:
  • Sonovue
Drug: platinum and gemcitabine
Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Disease Progression
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Kun Yan, master, Peking University Cancer Hospital & Institute
  • Principal Investigator: Lin Shen, Doctor, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

August 31, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014YJZ11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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