Celebrex and Metformin for Postoperative Hepatocellular Carcinoma (XBD)

Guangxi Medical University

Status and phase: Unknown; Phase 3

Conditions: Liver Cancer

Treatments: Drug: Celebrex plus Metformin; Drug: Celebrex; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03184493

Celebrex for HCC

Details and patient eligibility

About

This prospective trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing HCC recurrence after hepatic resection.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 4 patient groups

Celebrex

Experimental group

Description:

Patients will receive celebrex (1 piece/day, 0.2mg/piece, Pfizer Pharmaceuticals Ltd) until obvious side effects.

Treatment:

Drug: Celebrex

Metformin

Experimental group

Description:

Patients will receive metformin (1 piece/bid, 250 mg/piece) until obvious side effects.

Treatment:

Drug: Metformin

Celebrex plus Metformin

Active Comparator group

Description:

Patients will receive celebrex (1 piece/day, 0.2mg/piece, Pfizer Pharmaceuticals Ltd) until obvious side effects. In addition, patients will receive metformin (1 piece/bid, 250 mg/piece) until obvious side effects.

Treatment:

Drug: Celebrex plus Metformin

Empty control group

No Intervention group

Description:

This group patients will not receive any postoperative adjuvant therapy.