NCT02767375

Hepatic Arterial Infusion Chemotherapy(HAIC) for Hepatoma After Resection

Hepatic Arterial Infusion Chemotherapy as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma(HCC): A Prospective Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To study if the addition of HAIC following complete removal of early stage liver cancer of HCC will prevent or delay the recurrence of the disease. Half of the participant will receive two cycles of the HAIC after the hepatectomy, while the other half will return to the baseline surveillance schedule.

Detailed description

The high incidence of HCC recurrence following liver resection is a serious issue. The recurrent rate is as high as 50-60% at 3 years and 70-100% at 5 years. So to reduce the recurrence rate of HCC, some interventions had been tried in clinic, including transarterial chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these adjuvant therapies had been proved effective and the long term efficacy and clinical application remained further explored. HAIC had been prove to be effective adjuvant treatment in patients with liver metastasis of colorectal cancers in randomized controlled trials and meta-analysis, but the role of adjuvant HAIC after liver resection is controversial. The results getting from different randomized control trials varied significantly because of the bias of patient selection, different study design，the small size of sample, different drug used in chemotherapy and lack of proper stratification,so a big sample size, well patients selected and well designed randomized controlled trial is needed to further confirm the role of the postoperative HAIC. Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by the doctors to receive no adjuvant HAIC(control group) or HAIC (treatment group). All patients in the treatment group will receive 2 cycles of adjuvant HAIC within 3 months after liver resection. The outcomes of patients were evaluated during the 5-years follow up.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Oxaliplatin(OXA), 5-fluorouracil (5-FU)	for the HAIC treatment group OXA 85mg/m2, d1，0-4h 5-FU 1500mg/m2 d1, 4-24h 24 hours in d1 \& 2 , IA，q4-6 Weeks
PROCEDURE	Hepatic arterial catheter implantation	for the the HAIC treatment group: Hepatic arterial catheter implantation for HAIC

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2016-05-10
• Last updated: 2017-08-10

Locations

1 site across 1 country: China