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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
192
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
for the the HAIC treatment group: Hepatic arterial catheter implantation for HAIC
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGRecurrence Free Survival
Time frame: approximately 70 months from first patient first visit
Time to recurrence
Time frame: approximately 60 months from first patient first visit
Overall survival
Time frame: approximately 60 months from first patient first visit
Visual Analog Score for pain
Time frame: approximately 60 months from first patient first visit
Physicians Global Assessment to measure quality of life
Time frame: approximately 60 months from first patient first visit
Number of Participants With Abnormal Laboratory Values
Time frame: approximately 60 months from first patient first visit
Adverse Events That Are Related to Treatment
Time frame: approximately 60 months from first patient first visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.