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Trial record 2 of 2070 for:    Pancreatic Cancer AND Digestive System Neoplasms

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02233205
Recruitment Status : Unknown
Verified July 2015 by Kun Yan, Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : September 8, 2014
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Kun Yan, Beijing Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Device: ultrasonic microbubbles Drug: platinum and gemcitabine Phase 1 Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: Sonovue

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




Primary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233205


Contacts
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Contact: Yang Wei, Doctor 0086-10-88196195 13681408183@163.com
Contact: Yanjie Wang, Doctor 0086-10-88196941 philinsss@163.com

Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Wei Yang, Doctor    0086-10-88196195    13681408183@163.com   
Contact: Yanjie Wang, Doctor    0086-10-88196941    philinsss@163.com   
Sub-Investigator: Yan Li, Doctor         
Sub-Investigator: Wei Yang, Doctor         
Sub-Investigator: Jifang Gong, Doctor         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: Kun Yan, Master Beijing Cancer Hospital
Principal Investigator: Lin Shen, Doctor Beijing Cancer Hospital

Publications of Results:
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Responsible Party: Kun Yan, chief director, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02233205     History of Changes
Other Study ID Numbers: 2014YJZ11
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Kun Yan, Beijing Cancer Hospital:
microbubble
chemotherapy
alimentary
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs