Clinical trial · Interventional
Celebrex and Metformin for Postoperative Hepatocellular Carcinoma
NCT03184493CI-TRIAL-00038868XBDunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing HCC recurrence after hepatic resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Celebrex
- description
- Patients will receive celebrex (1 piece/day, 0.2mg/piece, Pfizer Pharmaceuticals Ltd) until obvious side effects.
- interventionNames
- Drug: Celebrex
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Patients will receive metformin (1 piece/bid, 250 mg/piece) until obvious side effects.
- interventionNames
- Drug: Metformin
- type
- ACTIVE_COMPARATOR
- label
- Celebrex plus Metformin
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDZhong 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 24716523
- BACKGROUNDLing 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 27959383
- BACKGROUNDKim 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 27861855
- BACKGROUNDChan 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 27775209
- BACKGROUNDZhou 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 27642100
- BACKGROUNDTong 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 28430638
- BACKGROUNDTong 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.