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

Gastrointestinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02233205
• Other study ID #: 2014YJZ11
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 31, 2014
• Last updated: July 23, 2015
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: Yang Wei, Doctor
• Phone: 0086-10-88196195
• Email: 13681408183[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Device:
• ultrasonic microbubbles
inject 1ml once and five times in 20min, locate the probe on the lesion at the same time

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Dewitte H, Van Lint S, Heirman C, Thielemans K, De Smedt SC, Breckpot K, Lentacker I. The potential of antigen and TriMix sonoporation using mRNA-loaded microbubbles for ultrasound-triggered cancer immunotherapy. J Control Release. 2014 Nov 28;194:28-36. — View Citation

Fan Z, Kumon RE, Deng CX. Mechanisms of microbubble-facilitated sonoporation for drug and gene delivery. Ther Deliv. 2014 Apr;5(4):467-86. doi: 10.4155/tde.14.10. Review. — View Citation

Feichtinger GA, Hofmann AT, Slezak P, Schuetzenberger S, Kaipel M, Schwartz E, Neef A, Nomikou N, Nau T, van Griensven M, McHale AP, Redl H. Sonoporation increases therapeutic efficacy of inducible and constitutive BMP2/7 in vivo gene delivery. Hum Gene T — View Citation

Kotopoulis S, Dimcevski G, Gilja OH, Hoem D, Postema M. Treatment of human pancreatic cancer using combined ultrasound, microbubbles, and gemcitabine: a clinical case study. Med Phys. 2013 Jul;40(7):072902. doi: 10.1118/1.4808149. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious and Non-Serious Adverse Events		1 month	Yes
Secondary	Time to Disease Progression		one year	No