Hepatocellular CarcinomaPhase 2HCCNCT03046979
Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC)
A Phase 2 study testing Apatinib in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before doing any research steps, the patient's informed consent must be obtained first.
- The diagnosis of HCC: histologic diagnosis or Alpha fetoprotein (AFP) with two kinds of imaging diagnosis.
- Patients of Barcelona stage(BCLC) C with first-line treatment failure or non tolerance to sorafenib.
- Ages of 18 to 75 years old.
- Child-Pugh score between 5-7 points, patients of Child-Pugh 7 points should be without ascites.
- Eastern Cooperative Oncology Group performance score (ECOG PS) is 0-1 point.
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- Adequate organ function meeting the following:
- Hemoglobin(HBG)≧9.0g/dl Neutrophil count(ANC) ≧1,500/mm3 Platelet count(PLT)≧50,000/ul Total bilirubin (TBIL)< 2mg/dL (3mg/dL, Child-Pugh B) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 5×ULN (upper limit of normal) ALP (alkaline phosphatase ) < 4×ULN PT (prothrombin time) >50% or PT-INR<2.3, <6 seconds or greater than that of the control
- For patients taking warfarin, at least once a week to a close monitoring of the patients, until, according to the standard of treatment, at every time of medication, the subjects' INR measurements has been stable
- SCr (serum creatinine) <1.5×ULN
- For pregnant women, the results of serum pregnancy tests must be negative within 14 days before initiation of treatment.
- All men and women who participated in the study had to take reliable contraceptive measures within the trial and two weeks of after the trial.
Who cannot join
- Patients of Child-Pugh 7 has serious uncontrolled ascites.
- Patients with serious cardiovascular disease.
- Patients with high blood pressure of unable to control.
- Patients has the history of HIV (human immunodeficiency virus) infection.
- Active clinical severe infection (> 2, NCI-CTCAE version 3).
- Need to drug treatment of patients with epilepsy (such as steroid or antiepileptic drugs)
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- Has a history of allogeneic organ transplantation.
- Patients with a history of physical signs or have a bleeding.
- Patients undergoing renal dialysis.
- Metastatic liver cancer.
- Patients with uncontrollable ascites.
- Patients with encephalopathy.
- Patients has history of gastrointestinal bleeding period of 30 days before join the study.
- Patients with a history of esophagus varicosity burst hemorrhage, then not effective treatment or therapy to prevent recurrence of bleeding.
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
The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC.
Read the detailed description
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of our previous clinical studies, we intends to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Apatinib
- Keywords
- apatinib, advanced 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.
ApatinibDrug
Also called apatinib mesylate tablets
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | a molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Measured: one year
Secondary outcomes (5)
Disease Control Rate (DCR)
Measured: one year
Progression free survival (PFS)
Measured: one year
Overall survival (OS)
Measured: one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[Quality of life]
Measured: one year
Incidence of Treatment-Emergent Adverse Events [Safety]
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startDec 2016
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ti Zhang, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046979
- Sponsor's protocol ID
- AHEAD-HBH002
- Acronym
- HCC
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: the plan to share IPD is under consideration.
Publications
Hou Z, Zhu K, Yang X, Chen P, Zhang W, Cui Y, Zhu X, Song T, Li Q, Li H, Zhang T. Apatinib as first-line treatment in patients with advanced hepatocellular carcinoma: a phase II clinical trial. Ann Transl Med. 2020 Sep;8(17):1047. doi: 10.21037/atm-20-2990.
PubMed 33145266
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC)
- ClinicalTrials.gov ID
- NCT03046979
- Acronym / sponsor ID
- HCC / AHEAD-HBH002
- Conditions
- Hepatocellular Carcinoma
- Keywords
- apatinib, advanced hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Feb 2017 (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.
The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC.
Detailed description
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of our previous clinical studies, we intends to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: Apatiniba molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Before doing any research steps, the patient's informed consent must be obtained first.
- The diagnosis of HCC: histologic diagnosis or Alpha fetoprotein (AFP) with two kinds of imaging diagnosis.
- Patients of Barcelona stage(BCLC) C with first-line treatment failure or non tolerance to sorafenib.
- Ages of 18 to 75 years old.
- Child-Pugh score between 5-7 points, patients of Child-Pugh 7 points should be without ascites.
Key exclusion criteria (14 listed)
- Patients of Child-Pugh 7 has serious uncontrolled ascites.
- Patients with serious cardiovascular disease.
- Patients with high blood pressure of unable to control.
- Patients has the history of HIV (human immunodeficiency virus) infection.
- Active clinical severe infection (> 2, NCI-CTCAE version 3).
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 |
|---|---|---|
| ApatinibAlso: apatinib mesylate tablets500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops. | Drug | Apatinib |
Primary outcome
Objective Response Rate(ORR)
Time frame: one year
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: one year
Progression free survival (PFS)
Time frame: one year
Overall survival (OS)
Time frame: one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[Quality of life]
Time frame: one year
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Derived from this study: PubMed 33145266Hou Z, Zhu K, Yang X, Chen P, Zhang W, Cui Y, Zhu X, Song T, Li Q, Li H, Zhang T. Apatinib as first-line treatment in patients with advanced hepatocellular carcinoma: a phase II clinical trial. Ann Transl Med. 2020 Sep;8(17):1047. doi: 10.21037/atm-20-2990.
- Individual participant dataSharing planned: Undecided. the plan to share IPD is under consideration.
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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 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 Apatinib 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 12 inclusion and 14 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 8 Feb 2017. 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 Ti Zhang, MD (13920350428, zhangti@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: one 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 NCT03046979, which also lists 1 linked publication.
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 8 Feb 2017.