Clinical trial NCT00817895: Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence
Official title: Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
liver resection
intraoperative chemotherapy
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: disease free survival
timeFrame: 2 years
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Shen Feng, MD.
role: STUDY_CHAIR
References: