NCT02672488

Brief 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. In this phase II study, safety and efficacy of the combination of metformin and sorafenib will be evaluated in patients with advanced hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2015

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 3, 2016

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

December 7, 2015

Last Update Submit

February 2, 2016

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    12 months or time to death

Secondary Outcomes (3)

  • Time To Progression

    12 months or time to death

  • Progression Free Survival

    12 months

  • Objective Response Rate

    12 months

Study Arms (2)

Sorafenib and Metformin

EXPERIMENTAL

Sorafenib 400μg tablet by mouth and Metformin 500mg tablet by mouth with meal, twice per day

Drug: SorafenibDrug: Metformin

Sorafenib Alone

ACTIVE COMPARATOR

Sorafenib 400μg tablet by mouth, twice per day

Drug: Sorafenib

Interventions

SorafenibDRUG

Standard treatment for advanced HCC

Also known as: Nexavar
Sorafenib AloneSorafenib and Metformin
MetforminDRUG

To evaluate the safety and efficacy of the combined treatment of Metformin and Sorafenib for advanced HCC

Also known as: Glucophage
Sorafenib and Metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

SorafenibMetformin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingBiguanidesGuanidinesAmidines

Study Officials

  • Ti Zhang, MD

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Yan, PhD

CONTACT

+862223340123chengdongyan916@163.com

Dongyan Cheng, MS

CONTACT

+862223359984chengdongyan916@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

February 3, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

February 3, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share

Locations

CN(1)