CClinicalTrials.gg
Status unknownNCT01236690Updated Jun 28, 2011

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

A Phase 2 interventional study of Cinobufacin injection in Hepatoma and Cinobufacin Injection, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-06-28.

Sponsored by Changhai Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
284
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 .

Read the detailed description

Inclusion criterion :

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

Exclusion criterion :

  1. Main portal vein was obstructed completely.
  2. The occupation of tumor are 70 % or more than 70 % in the whole liver
  3. The patient has TACE or other antineoplaston
  4. After carcinosectomy the patient has the prophylactic
  5. The patient is with renal inadequacy: Cr≥133 umol/L
  6. Severe cardiovascular disease
  7. The patient is with other diseases to influence the proposal
02

Conditions studied

  • Hepatoma
  • Cinobufacin Injection

Keywords

  • Transcatheter arterial embolization
  • Cinobufacin injection
  • hepatoma
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 284 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Main portal vein was obstructed completely;
  2. The occupation of tumour are 70 % or more than 70 % in the whole liver;
  3. The patient has recepted TACE or other antineoplaston;
  4. After carcinosectomy the patient has the prophylactic;
  5. The patient is with renal inadequacy: Cr≥133 umol/L
  6. Severe cardiovascular disease;
  7. The patient is with other diseases to influence the proposal;
  8. All over the body generally have metabasis or be with other malignant neoplastic disease;
  9. In the process of participation of other medicinal trial;
  10. Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
284 participants (estimated)

Interventions

  • DrugCinobufacin injection

    Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy

    Also known as: Z34020273

06

What researchers measure

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.

    Time frame: Nov. 2010 to Nov. 2013

07

Study locations

1 of 1 sites recruiting
  • Department of TCM, Changhai Hospital of Shanghai
    Shanghai, Shanghai 200433, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01236690
Lead sponsor
Changhai Hospital
First posted
Nov 9, 2010
Start date
Nov 2010
Primary completion
Oct 2013 (estimated)
Completion
Nov 2013 (estimated)
Last update
Jun 28, 2011

Study contacts

Ling chang quan, doctor
principal investigator · Changhai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion