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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02233205
Other study ID # 2014YJZ11
Secondary ID
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

- ECOGĀ«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


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
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