Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

Hepatocellular Carcinoma Clinical Trial

Official title:

Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-Term Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00817895
• Other study ID #: EHBH-RCT-2008-010
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2009
• Last updated: January 6, 2009
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2009
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Feng Xu, MD.
• Phone: 86-21-25070773
• Email: victorf2255[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.

Description:

150 HCC patients with tumor >5cm, multiple tumor and who cannot accept R0 resection will be randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50 cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All patients will accepted TACE 30 days after liver resection. We will follow up all patients until they are dead or missed connected. Related adverse reaction will be recorded. Total survival time (TST) and disease free survival time (DFST) will be calculated too. At the end of the study we will compare the difference of adverse reaction, complication, TST and DFST between the 3 groups. According to the result we will estimate these drugs' antitumor effect and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. tumor >5cm;

2. multiple tumor located in one liver lobe;

3. margin of tumor is not clear;

4. cutting edge to tumor <1cm;

5. portal vein branch invasion;

6. without extra-liver metastasis;

7. patient's liver function and condition is able to accept hepatectomy.

Exclusion Criteria:

1. single tumor <=5cm;

2. multiple tumor located more than in one liver lobe;

3. margin of tumor is clear;

4. cutting edge to tumor >=1cm;

5. portal vein stem invasion

6. extra-liver metastasis;

7. patient's liver function and condition cannot accept hepatectomy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• sustained released 5-FU and sustained released cisplatin
600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.
• sustained released 5-FU
600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.

Procedure:
• TACE
All patients will accept TACE one month after tumor was resected.

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		2 years	No
Secondary	overall survival		2 years	No