NCT03184493

Celebrex and Metformin for Postoperative Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	Celebrex plus Metformin	This group patients will receive metformin and celebrex.
DRUG	Celebrex	This group patients will receive celebrex.
DRUG	Metformin	This group patients will receive metformin.

Timeline

• Start date: 2017-06-02
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2017-06-12
• Last updated: 2019-05-31

Locations

1 site across 1 country: China