Biliary Tract CancerPhase 2NCT03144856
Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancers
A Phase 2 study testing Apatinib in people with Biliary Tract Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
This study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesChina
- Study dates
- 22 Feb 2017to 1 Mar 2019
- 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
- Must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
- Patients with ampullary carcinoma are not eligible.
- Must have failed or are intolerant to one line of systemic treatment but no more than 2 prior lines of systemic chemotherapy for advanced BTC. Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence.
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or 1.
- Must have radiographic measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
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- Life expectancy of at least 12 weeks (3 months).
- For patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy; Lesions that have not been treated with local therapy must be present and measureable.
- Must be able to understand and be willing to sign the written informed consent form. Must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements.
- All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) except for alopecia.
- Adequate bone marrow, liver and liver function.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug.
- Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug.
Who cannot join
- Pregnant or lactating women;
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- Uncontrolled hypertension;
- Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
- Urine protein>grade 1;
- Any factors that influence the usage of oral administration;
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- Patients with a clear tendency of gastrointestinal bleeding;
- Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
- Abuse of alcohol or drugs;
- Less than 4 weeks from the last clinical trial;
- Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
- Active central nervous system (CNS). If CNS metastases are treated and potential participants are at neurologic baseline for at least 2 weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to enrollment. 13. Disability of serious uncontrolled intercurrence infection.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Foshan people's Hospital
Foshan, Guangdong
Wei Wang, 075783161035, m18038863618@163.com
- Recruiting
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
Fenghua Wang, MD, PhD, 86-020-87342490, wangfh@sysucc.org.cn
Miao-Zhen Qiu, MD, PhD, 86-020-87342490, qiumzh@sysucc.org.cn
About this study
Official title: Phase II Study of Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancer
This study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers.
Read the detailed description
Biliary tract cancers (BTC) includes cholangiocarcinoma and gallbladder carcinoma (GBC). The systematic treatment based on gemcitabine plus cisplatin is recommended as the current standard chemotherapy for unresectable or metastatic BTC. There is no standard recommendation for second line therapy.
Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2).
This study was conducted to assess the efficacy and safety of Apatinib in patients with advanced refractory BTC who had received first-line chemotherapy.
- Conditions
- Biliary Tract Cancer
- Being tested
- Apatinib
- Keywords
- Biliary Tract Cancer, Second line thrapy, Apatinib
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib 500mg, po, qd, every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib group | Experimental | Apatinib 500mg, po, QD, every 4 weeks. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy
Measured: Approximately 1 year
Secondary outcomes (4)
Overall survival (OS)
Defined as the time from randomize to death
Measured: Approximately 2 years
Disease control rate(DCR)
Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines
Measured: Approximately 1 year
Quality of life(QoL)
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Measured: Approximately 1 year
Safety (incidence of adverse events)
Incidence of adverse events
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start22 Feb 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Model description
- Apatinib single agent
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Fenghua Wang, Sun Yat-sen University
- Investigators
- Rui-Hua Xu, MD, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144856
- Sponsor's protocol ID
- Apatinib_BTC
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT03144856
- Acronym / sponsor ID
- Apatinib_BTC
- Conditions
- Biliary Tract Cancer
- Keywords
- Biliary Tract Cancer, Second line thrapy, Apatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 9 May 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 study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers.
Detailed description
Biliary tract cancers (BTC) includes cholangiocarcinoma and gallbladder carcinoma (GBC). The systematic treatment based on gemcitabine plus cisplatin is recommended as the current standard chemotherapy for unresectable or metastatic BTC. There is no standard recommendation for second line therapy.
Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2).
This study was conducted to assess the efficacy and safety of Apatinib in patients with advanced refractory BTC who had received first-line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Apatinib single agent
| Arm | Type | Receives |
|---|---|---|
| Apatinib group | Experimental | Drug: ApatinibApatinib 500mg, po, QD, every 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
- Patients with ampullary carcinoma are not eligible.
- Must have failed or are intolerant to one line of systemic treatment but no more than 2 prior lines of systemic chemotherapy for advanced BTC. Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence.
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or 1.
Key exclusion criteria (12 listed)
- Pregnant or lactating women;
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- Uncontrolled hypertension;
- Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
- Urine protein>grade 1;
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 500mg, po, qd, every 4 weeks. | Drug | Apatinib group |
Primary outcome
Progression-free survival (PFS)
Time frame: Approximately 1 year
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy
4 secondary outcomes
Overall survival (OS)
Time frame: Approximately 2 years
Disease control rate(DCR)
Time frame: Approximately 1 year
Quality of life(QoL)
Time frame: Approximately 1 year
Safety (incidence of adverse events)
Time frame: Approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Rui-Hua Xu, MD, PhD principal investigator
Sun Yat-Sen University Cancer Center
2 sites 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 Biliary Tract Cancer, run by Sun Yat-sen University at 2 sites 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 13 inclusion and 12 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Feng-Hua Wang, MD, PhD (86-020-87342490, wangfh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Approximately 1 year). 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 9 May 2017.