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Completed

NCT Number: NCT00817895

Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • tumor >5cm;
  • multiple tumor located in one liver lobe;
  • margin of tumor is not clear;
  • cutting edge to tumor <1cm;
  • portal vein branch invasion;
  • without extra-liver metastasis;
  • patient's liver function and condition is able to accept hepatectomy.

Exclusion criteria

  • single tumor <=5cm;
  • multiple tumor located more than in one liver lobe;
  • margin of tumor is clear;
  • cutting edge to tumor >=1cm;
  • portal vein stem invasion
  • extra-liver metastasis;
  • patient's liver function and condition cannot accept hepatectomy.

Treatment and study plan

sustained released 5-FU and sustained released cisplatin

Drug

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

Other names: 5-FU+Cisplatin group

sustained released 5-FU

Drug

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

Other names: 5-FU group

TACE

Procedure

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

Other names: Postoperative TACE

Primary outcomes

  1. disease free survival

    Time frame: 2 years

Secondary outcomes

  1. overall survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 7, 2009
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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