Hepatocellular CarcinomaPhase 1/2NCT02727309
A Study of Second-line Treatment With Apatinib After TACE in Advanced Hepatocellular Carcinoma Patients
A Phase 1/2 study testing Apatinib in people with Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- Oct 2015to Mar 2019
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a histologic or cytologic diagnosis of hepatocellular carcinoma
- Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment
- The previous chemotherapy and the present trial registration must be at least 2 weeks apart. And they must have recovered from any toxicity of a previous chemotherapy
- Patients with Child Pugh Class A \& B disease are eligible for the study
- Patients with Barcelona Clinic Liver Cancer stage B or C are eligible for the study
- Eastern Cooperative Oncology Group performance score (PS): 0-2
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- Life expectancy of at least 12 weeks
- Hepatitis B virus DNA<2000 IU/ml
- Adequate organ function meeting the following:
- Bone marrow: absolute neutrophil count ≥1.5×109/L (1500/mm3); platelet ≥ 75×109/L; hemoglobin ≥9 g/dL
- Liver: Serum bilirubin ≤ 1.5 ×ULN, AST and ALT ≤ 5 ×ULN, ALB ≥ 29 g/L
- Kidney: Cr ≤1.5 ×upper limit of normal
- Within 7 days prior to the start of therapy, women of child-bearing potential must undergo a pregnancy test, which must be negative; men of child-bearing potential: contraceptive measures must be adopted during treatment and within 8 weeks afterward
- Subjects who understand and voluntarily signed a written informed consent form
Who cannot join
- Previous locoregional therapy within 4 weeks prior to enrollment
- Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma
- History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
- Prepared for liver transplantation
- Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
- A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence
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- Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
- Patients with central nervous system metastases or brain metastasis
- Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia
- Pregnant or lactating women
- Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Interventional Therapy
Beijing, Beijing Municipality, 100142
Xu Zhu, MD, +86-10-88196476, drzhuxu@163.com
About this study
Official title: A Pilot Study of Second-line Treatment With Apatinib After Trans Arterial Chemoembolization (TACE) in Advanced Hepatocellular Carcinoma Patients
This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Apatinib
- Keywords
- Apatinib, Second-line Treatment, Hepatocellular Cancer, TACE
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib: 750 mg is administered orally daily, until disease progression or untolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| apatinib | Experimental | Patients with advanced hepatocellular carcinoma after been treated with TACE receive apatinib (750mg) daily, until disease progression or unacceptable toxicity. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.
Measured: 6 months
Secondary outcomes (2)
Overall survival
Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause
Measured: 2 years
Objective response rates
Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 6 weeks following the date of the initial response.
Measured: 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (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.
- More trials run by Peking University Cancer Hospital & InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Zhuxu, Peking University Cancer Hospital & Institute
- Investigators
- Xu Zhu, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727309
- Sponsor's protocol ID
- AHEAD-HBH001
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2016
- Last updated
- 4 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Second-line Treatment With Apatinib After Trans Arterial Chemoembolization (TACE) in Advanced Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT02727309
- Acronym / sponsor ID
- AHEAD-HBH001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Apatinib, Second-line Treatment, Hepatocellular Cancer, TACE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 4 Apr 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.
This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS.
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: ApatinibPatients with advanced hepatocellular carcinoma after been treated with TACE receive apatinib (750mg) daily, until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with a histologic or cytologic diagnosis of hepatocellular carcinoma
- Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment
- The previous chemotherapy and the present trial registration must be at least 2 weeks apart. And they must have recovered from any toxicity of a previous chemotherapy
- Patients with Child Pugh Class A \& B disease are eligible for the study
- Patients with Barcelona Clinic Liver Cancer stage B or C are eligible for the study
Key exclusion criteria (11 listed)
- Previous locoregional therapy within 4 weeks prior to enrollment
- Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma
- History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
- Prepared for liver transplantation
- Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
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 |
|---|---|---|
| ApatinibApatinib: 750 mg is administered orally daily, until disease progression or untolerable toxicity. | Drug | apatinib |
Primary outcome
Progression free survival
Time frame: 6 months
A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.
2 secondary outcomes
Overall survival
Time frame: 2 years
Objective response rates
Time frame: 1.5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
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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.
Xu Zhu, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apatinib in people with Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute 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 11 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 4 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xu Zhu, MD (+86-10-88196476, drzhuxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 6 months). 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 4 Apr 2016.