Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00817895

Enrollment

150

Registered

2009-01-07

Start date

2008-12-31

Completion date

2010-12-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, liver resection, intraoperative chemotherapy

Brief 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.

Detailed 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.

Interventions

DRUGsustained 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.

DRUGsustained released 5-FU

600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.

PROCEDURETACE

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
disease free survival	2 years

Secondary

Measure	Time frame
overall survival	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026