Liver Cancer
Conditions
Brief summary
This prospective trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing HCC recurrence after hepatic resection.
Detailed description
Hepatic resection is a popular curative treatment for patients with early-stage HCC and well-preserved liver function. Although overall survival after resection has been increasing, the median 5-year disease-free survival rate after resection remains at only about 37% for early-stage HCC. In fact, the 5-year recurrence rate is as high as 74% for intermediate and advanced HCC. Postoperative recurrence may be due to intrahepatic metastasis arising from the primary tumor or it may be de novo metastasis (multicentric) that arises spontaneously in the residual liver. Intrahepatic metastasis is the primary mechanism of early recurrence, which occurs \<2 years after resection; multicentric metastasis is the principal mechanism behind late recurrence, which occurs at least 2 years after resection. In the past few years, some observational studies with small sample size found metformin and celebrex (selective cyclic oxidase-2 inhibitors) may reduce the rate of HCC after surgery. However, no prospective study compare their efficacy in preventing HCC recurrence. This trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing HCC recurrence after hepatic resection.
Interventions
DRUGCelebrex plus Metformin
This group patients will receive metformin and celebrex.
DRUGCelebrex
This group patients will receive celebrex.
DRUGMetformin
This group patients will receive metformin.
Sponsors
Guangxi Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients * Patients have Child-Pugh A or B liver function * No previous neoadjuvant treatment * No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings * No malignancy other than HCC for 5 years prior to the initial HCC treatment
Exclusion criteria
* History of cardiac disease * Known history of human immunodeficiency virus (HIV) infection * Known Central Nervous System tumors including metastatic brain disease * History of organ allograft * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study Pregnant or breast-feeding patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with tumor recurrence | 1-year | The 1-year tumor recurrence will be compared between the three groups |
Countries
China
Contacts
Primary ContactBang-De Xiang, PhD
Outcome results
None listed