Celebrex and Metformin for Postoperative Hepatocellular Carcinoma
XBD
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2017
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2017
CompletedFirst Submitted
Initial submission to the registry
June 9, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMay 31, 2019
May 1, 2019
3.5 years
June 9, 2017
May 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with tumor recurrence
The 1-year tumor recurrence will be compared between the three groups
1-year
Study Arms (4)
Celebrex
EXPERIMENTALPatients will receive celebrex (1 piece/day, 0.2mg/piece, Pfizer Pharmaceuticals Ltd) until obvious side effects.
Metformin
EXPERIMENTALPatients will receive metformin (1 piece/bid, 250 mg/piece) until obvious side effects.
Celebrex plus Metformin
ACTIVE COMPARATORPatients 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.
Empty control group
NO INTERVENTIONThis group patients will not receive any postoperative adjuvant therapy.
Interventions
This group patients will receive metformin and celebrex.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Tumor Hospital of Guangxi Medical University
Nanjing, Guangxi, 530021, China
Related Publications (7)
Zhong JH, Ma L, Li LQ. Postoperative therapy options for hepatocellular carcinoma. Scand J Gastroenterol. 2014 Jun;49(6):649-61. doi: 10.3109/00365521.2014.905626. Epub 2014 Apr 10.
PMID: 24716523BACKGROUNDLing S, Song L, Fan N, Feng T, Liu L, Yang X, Wang M, Li Y, Tian Y, Zhao F, Liu Y, Huang Q, Hou Z, Xu F, Shi L, Li Y. Combination of metformin and sorafenib suppresses proliferation and induces autophagy of hepatocellular carcinoma via targeting the mTOR pathway. Int J Oncol. 2017 Jan;50(1):297-309. doi: 10.3892/ijo.2016.3799. Epub 2016 Dec 9.
PMID: 27959383BACKGROUNDKim G, Jang SY, Han E, Lee YH, Park SY, Nam CM, Kang ES. Effect of statin on hepatocellular carcinoma in patients with type 2 diabetes: A nationwide nested case-control study. Int J Cancer. 2017 Feb 15;140(4):798-806. doi: 10.1002/ijc.30506. Epub 2016 Nov 16.
PMID: 27861855BACKGROUNDChan KM, Kuo CF, Hsu JT, Chiou MJ, Wang YC, Wu TH, Lee CF, Wu TJ, Chou HS, Lee WC. Metformin confers risk reduction for developing hepatocellular carcinoma recurrence after liver resection. Liver Int. 2017 Mar;37(3):434-441. doi: 10.1111/liv.13280. Epub 2016 Nov 13.
PMID: 27775209BACKGROUNDZhou YY, Zhu GQ, Liu T, Zheng JN, Cheng Z, Zou TT, Braddock M, Fu SW, Zheng MH. Systematic Review with Network Meta-Analysis: Antidiabetic Medication and Risk of Hepatocellular Carcinoma. Sci Rep. 2016 Sep 19;6:33743. doi: 10.1038/srep33743.
PMID: 27642100BACKGROUNDTong H, Wei B, Chen S, Xie YM, Zhang MG, Zhang LH, Huang ZY, Tang CW. Adjuvant celecoxib and lanreotide following transarterial chemoembolisation for unresectable hepatocellular carcinoma: a randomized pilot study. Oncotarget. 2017 Jul 18;8(29):48303-48312. doi: 10.18632/oncotarget.15684.
PMID: 28430638BACKGROUNDTong H, Li X, Wei B, Tang C. Combinative treatment of transarterial chemoembolization, celecoxib and lanreotide in unresectable hepatocellular carcinoma. Clin Res Hepatol Gastroenterol. 2015 Oct;39(5):e65-6. doi: 10.1016/j.clinre.2015.01.008. Epub 2015 Mar 4. No abstract available.
PMID: 25746137BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 9, 2017
First Posted
June 12, 2017
Study Start
June 2, 2017
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
May 31, 2019
Record last verified: 2019-05