A randomized controlled trial of intra-arterial infusion of CDDP for hepatocellular carcinoma to prevent intra-hepatic metastasis after curative resection

UMIN ID: UMIN000001138

Registered date:01/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients after curative resection of hepatocellular carcinoma
• Date of first enrollment: 2008/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A: No additional treatment after curative resection
Group B: Intra-arterial infusion of CDDP after curative resection An amount of 65mg/square meter of body surface of CDDP dissolved in saline at the concentration of 100 mg/70 ml is infused targeting the entire residual liver through a catheter inserted into an appropriate artery on 8, 20 and 32 weeks after curative surgical resection of hepatocellular carcinoma. The infusion rate is 3 mg/min, and two weeks earlier or later date is acceptable. When creatinine clearance is less than 90 ml/min or 70 ml/min, the amount of CDDP is reduced to 70% or 50%, respectively. If the previous infusion required additional treatments against adverse effects at Grade 3 of Common Terminology Criteria for Adverse Events v3.0 in terms of WBC, RBC and/or Plt, the amount of CDDP is reduced to 80% in the following infusion.

Outcome(s)

• Primary Outcome: 1. Survival 2. Recurrence-free survival based on the evaluation using computed tomography, magnetic resonance imaging or ultrasound. The evaluation should be conducted every three months and has to be performed with computed tomography or magnetic resonance imaging at least once a 6-months. 3. A way of recurrence
• Secondary Outcome: 1. RBC, WBC including differential count, Plt, PT-INR , Bleeding time 2. TP, Alb, AST, ALT, ALP, LDH, gamma-GTP, TBil, BUN, Crt, Na, K, Cl, ChE, T Chol, HbA1c 3. Alpha-fetoprotein, Fucosylated fraction of alpha-fetoprotein, Des-gamma-carboxy prothrombin 4. Urinalysis, Creatinine clearance 5. Background a. Age, Gender, Performance status, Chest X-ray, ECG b. HBsAg, anti-HCV, Child-Pugh classification, Indocyanine green retention rate R15 and clearance rate c. Characteristics of hepatocellular carcinoma: diagnostic modality, size, number, location, extension to hepatic and/or portal vein d. Alcoholic consumption, Blood transfusion, History of treatment for hepatocellular carcinoma and/or other diseases, History of allergy Items from #1 to #3 and #4 are evaluated once a month and just before each infusion of CDDP, respectively, while those in #5 are evaluated only at the enrolment.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. The history of severe allergic reaction against iodinated contrast medium and/or platinum-containing drugs. 2. A woman who is pregnant, lactating, or may become pregnant. 3. Hepatocellular carcinoma extended to the first branch of the portal vein or further. 4. Hepatocellular carcinoma extended to the inferior vena cava or further. 5. Dynamic CT or dynamic MRI revealed that hepatocellular carcinoma is solitary and 2 cm or less without vascular invasion. 6. Under interferon therapy. 7. A doctor responsible for the study judged to be inappropriate.

Related Information

• Primary Sponsor: Niigata Hepatocellular Carcinoma Therapy Study Group
• Source(s) of Monetary Support: None