Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy

NCT01236690 | Unknown Phase 2 DMC

• 1 other identifier: CLing
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas. Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .

Conditions

Hepatoma; Cinobufacin Injection

Keywords

Transcatheter arterial embolization; Cinobufacin injection; hepatoma

Outcome Measures

Primary Outcomes (1)

• The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.

  The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.

  Nov. 2010 to Nov. 2013

Interventions

Cinobufacin injection DRUG

Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy

Also known as: Z34020273

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The sex does not limit, age:18-70 years old ;
• The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation\< 70 %;
• The patients have failure in surgical intervention or resection operation recidivist;
• Hepatic function Child-pugh A、B;
• All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ;
• The patient's prediction of live time\>6 months, who can tolerant of TACE and has quality of life ECOG score\<3;
• The patients participate the clinical trial voluntarily and have already signed informed consent.

You may not qualify if:

• Main portal vein was obstructed completely;
• The occupation of tumour are 70 % or more than 70 % in the whole liver;
• The patient has recepted TACE or other antineoplaston;
• After carcinosectomy the patient has the prophylactic;
• The patient is with renal inadequacy: Cr≥133 umol/L
• Severe cardiovascular disease;
• The patient is with other diseases to influence the proposal;
• All over the body generally have metabasis or be with other malignant neoplastic disease;
• In the process of participation of other medicinal trial;
• Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Department of TCM, Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

huachansu

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ling chang quan, doctor

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 28, 2011

Record last verified: 2010-10

Locations

CN (1)