Liver CancerPhase 3XBDNCT03184493
Celebrex and Metformin for Postoperative Hepatocellular Carcinoma
A Phase 3 study testing Celebrex plus Metformin, Celebrex and Metformin in people with Liver Cancer, run by Guangxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Celebrex plus Metformin, Celebrex and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2017to Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanjing, Guangxi, 530021
Bang-de Xiang, PhD, 7715330855, xiangbangde@163.com
About this study
This prospective trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing HCC recurrence after hepatic resection.
Read the 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
- Being tested
- Celebrex plus Metformin, Celebrex, Metformin
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celebrex plus MetforminDrug
This group patients will receive metformin and celebrex.
CelebrexDrug
This group patients will receive celebrex.
MetforminDrug
This group patients will receive metformin.
| Study group | Role | What they receive |
|---|---|---|
| Celebrex | Experimental | Patients will receive celebrex (1 piece/day, 0.2mg/piece, Pfizer Pharmaceuticals Ltd) until obvious side effects. Receives: Drug: Celebrex |
| Metformin | Experimental | Patients will receive metformin (1 piece/bid, 250 mg/piece) until obvious side effects. Receives: Drug: Metformin |
| Celebrex plus Metformin | Active comparator | 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. Receives: Drug: Celebrex plus Metformin |
| Empty control group | No intervention | This group patients will not receive any postoperative adjuvant therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with tumor recurrence
The 1-year tumor recurrence will be compared between the three groups
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start2 Jun 2017
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184493
- Sponsor's protocol ID
- Celebrex for HCC
- Acronym
- XBD
- Status last verified
- May 2019
- First submitted
- 9 Jun 2017
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24716523Ling 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.
PubMed 27959383Kim 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.
PubMed 27861855Chan 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.
PubMed 27775209Zhou 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.
PubMed 27642100Tong 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.
PubMed 28430638Tong 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.
PubMed 25746137
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celebrex and Metformin for Postoperative Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03184493
- Acronym / sponsor ID
- XBD / Celebrex for HCC
- Conditions
- Liver Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Celebrex | Experimental | Drug: CelebrexPatients will receive celebrex (1 piece/day, 0.2mg/piece, Pfizer Pharmaceuticals Ltd) until obvious side effects. |
| Metformin | Experimental | Drug: MetforminPatients will receive metformin (1 piece/bid, 250 mg/piece) until obvious side effects. |
| Celebrex plus Metformin | Active comparator | Drug: Celebrex plus MetforminPatients 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 intervention | –This group patients will not receive any postoperative adjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celebrex plus MetforminThis group patients will receive metformin and celebrex. | Drug | Celebrex plus Metformin |
| CelebrexThis group patients will receive celebrex. | Drug | Celebrex |
| MetforminThis group patients will receive metformin. | Drug | Metformin |
Primary outcome
Number of participants with tumor recurrence
Time frame: 1-year
The 1-year tumor recurrence will be compared between the three groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Background: PubMed 24716523Zhong 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.
- Background: PubMed 27959383Ling 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.
- Background: PubMed 27861855Kim 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.
- Background: PubMed 27775209Chan 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.
- Background: PubMed 27642100Zhou 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.
- Background: PubMed 28430638Tong 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.
- Background: PubMed 25746137Tong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celebrex plus Metformin, Celebrex and Metformin in people with Liver Cancer, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bang-De Xiang, PhD (0771-5330855, xiangbangde@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with tumor recurrence (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03184493, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.