Hepatocellular CarcinomaPhase 2NCT02672488
Metformin Plus Sorafenib for Advanced HCC
A Phase 2 study testing Sorafenib and Metformin in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. It has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
- Confirmed hepatocellular carcinoma according to one of following three criteria:
- histopathology,Two radiographic techniques (US, MRI, CT, or Angiography) that confirm lesion with typical arterial hypervascularization,Barcelona Clinical Liver Cancer staging C (BCLC-C)
- Age > 18 years old
- Patients with liver disease classified as Child Pugh class A
- Eastern Clinical Oncology Group (ECOG) performance status 0，1 or 2 (Appendix I)
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- Hemoglobin ≥ 9 g/dL
- Absolute Neutrophil count（ANC）≥ 1,500 /mm3
- Platelet count≥ 50,000 /ul
- Total Bilirubin < 2 mg/dL
- Transaminases (SGOT and SGPT) no more than 5 times the upper limit of normal
- Alkaline phosphatase < 4 times the upper limit of normal
- Both men and women and members of all races and ethnic groups are eligible for this study
- Prothrombin time > 50% 或 PT-INR < 2.3
Who cannot join
- Child Pugh Score is 7 with ascites
- Severe cardiovascular disease
- Uncontrollable hypertension
- History of HIV infection
- Active clinical severe infection（>grade 2 ，NCI-CTCAE Version3.0）
- Women who are pregnant
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- Administration of any systemic chemotherapy within the last 6 months
- Presence of History of gastrointestinal bleeding before randomization
- Epileptic seizures requiring drug therapy
- History of allograft transplantation
- Patients with signs of bleeding or medical history
- Patients undergoing kidney dialysis
- Metastatic liver cancer
- Uncontrollable ascites
- Encephalopathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
TI ZHANG, MD, +862223340123 ext. 3092, zhangti@tjmuch.com
Huikai Li, MD, +862223340123 ext. 3091, lihuikai@tjmuch.com
About this study
Official title: Safety and Efficacy of Metformin Plus Sorafenib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma(BCLC-C): A Phase 2 Randomized Study
Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. It has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. In this phase II study, safety and efficacy of the combination of metformin and sorafenib will be evaluated in patients with advanced hepatocellular carcinoma.
Read the detailed description
Sorafenib is the standard choice for advanced hepatocellular carcinoma (BCLC-C), but the efficacy is not satisfied. Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. It has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. Recent studies suggest that metformin treatment can reduce the risk of HCC in patients with type 2 diabetes and inhibit HCC invasion and increase drug sensitivity to sorafenib, however, the safety and efficacy of combined therapy for advanced hepatocellular carcinoma remains unclear. In this phase II study, patients with advanced hepatocellular carcinoma, measurable disease, and an Eastern Cooperative Oncology Group performance score≤1 will be enrolled. Eligible subjects will be randomly assigned to receive the treatment of sorafenib or metformin plus sorafenib. The potential improvement of overall survival, time to progression and safety will be evaluated.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
Standard treatment for advanced HCC
MetforminDrug
Also called Glucophage
To evaluate the safety and efficacy of the combined treatment of Metformin and Sorafenib for advanced HCC
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and Metformin | Experimental | Sorafenib 400μg tablet by mouth and Metformin 500mg tablet by mouth with meal, twice per day Receives: Drug: Sorafenib; Drug: Metformin |
| Sorafenib Alone | Active comparator | Sorafenib 400μg tablet by mouth, twice per day Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 12 months or time to death
Secondary outcomes (3)
Time To Progression
Measured: 12 months or time to death
Progression Free Survival
Measured: 12 months
Objective Response Rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Harbin Medical University, Liaoning Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Fudan University
- Responsible party
- Sponsor
- Investigators
- Ti Zhang, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672488
- Sponsor's protocol ID
- METSOR
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Metformin Plus Sorafenib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma(BCLC-C): A Phase 2 Randomized Study
- ClinicalTrials.gov ID
- NCT02672488
- Acronym / sponsor ID
- METSOR
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Harbin Medical University, Liaoning Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Fudan University
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- 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.
Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. It has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. In this phase II study, safety and efficacy of the combination of metformin and sorafenib will be evaluated in patients with advanced hepatocellular carcinoma.
Detailed description
Sorafenib is the standard choice for advanced hepatocellular carcinoma (BCLC-C), but the efficacy is not satisfied. Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. It has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. Recent studies suggest that metformin treatment can reduce the risk of HCC in patients with type 2 diabetes and inhibit HCC invasion and increase drug sensitivity to sorafenib, however, the safety and efficacy of combined therapy for advanced hepatocellular carcinoma remains unclear. In this phase II study, patients with advanced hepatocellular carcinoma, measurable disease, and an Eastern Cooperative Oncology Group performance score≤1 will be enrolled. Eligible subjects will be randomly assigned to receive the treatment of sorafenib or metformin plus sorafenib. The potential improvement of overall survival, time to progression and safety will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and Metformin | Experimental | Drug: Sorafenib, Drug: MetforminSorafenib 400μg tablet by mouth and Metformin 500mg tablet by mouth with meal, twice per day |
| Sorafenib Alone | Active comparator | Drug: SorafenibSorafenib 400μg tablet by mouth, twice per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
- Confirmed hepatocellular carcinoma according to one of following three criteria:
- histopathology,Two radiographic techniques (US, MRI, CT, or Angiography) that confirm lesion with typical arterial hypervascularization,Barcelona Clinical Liver Cancer staging C (BCLC-C)
- Age > 18 years old
- Patients with liver disease classified as Child Pugh class A
Key exclusion criteria (15 listed)
- Child Pugh Score is 7 with ascites
- Severe cardiovascular disease
- Uncontrollable hypertension
- History of HIV infection
- Active clinical severe infection（>grade 2 ，NCI-CTCAE Version3.0）
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 |
|---|---|---|
| SorafenibAlso: NexavarStandard treatment for advanced HCC | Drug | Sorafenib Alone, Sorafenib and Metformin |
| MetforminAlso: GlucophageTo evaluate the safety and efficacy of the combined treatment of Metformin and Sorafenib for advanced HCC | Drug | Sorafenib and Metformin |
Primary outcome
Overall Survival
Time frame: 12 months or time to death
3 secondary outcomes
Time To Progression
Time frame: 12 months or time to death
Progression Free Survival
Time frame: 12 months
Objective Response Rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Ti Zhang, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib and Metformin in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 14 inclusion and 15 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 3 Feb 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhao Yan, PhD (+862223340123 ext. 6012, chengdongyan916@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 12 months or time to death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2016.