Biliary Tract NeoplasmsPhase 2NCT02558959
Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
A Phase 2 study testing Irinotecan and Capecitabine in people with Biliary Tract Neoplasms, run by Zhejiang University at 1 site in China.
Trial summary
This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Neoplasms
- What is being tested?
- Irinotecan and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2015to 31 Dec 2017
- 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
- Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
- Age 18 years or older
- Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
- Karnofsky performance status (KPS) of at least 70%
- Adequate renal function, adequate hepatic function, adequate bone marrow function
Who cannot join
- The presence of any severe concomitant disease that could interrupt the planned treatment
- Intractable pain
- Hypersensitivity to study drugs
- Serious cardiovascular disease
- If female, pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
Official title: Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study
This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.
- Conditions
- Biliary Tract Neoplasms
- Being tested
- Irinotecan, Capecitabine
- 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.
IrinotecanDrug
CapecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan and Capecitabine | Experimental | irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w Receives: Drug: Irinotecan; Drug: Capecitabine |
| Irinotecan | Active comparator | irinotecan 180mg/m2 d1, q2w Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
PFS
Measured: within 1 year
Secondary outcomes (1)
Overall Survival
OS
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558959
- Sponsor's protocol ID
- ZYYYMedOncoBIL01
- Status last verified
- Feb 2018
- First submitted
- 21 Sep 2015
- Last updated
- 13 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02558959
- Acronym / sponsor ID
- ZYYYMedOncoBIL01
- Conditions
- Biliary Tract Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Sep 2015 (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 investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan and Capecitabine | Experimental | Drug: Irinotecan, Drug: Capecitabineirinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w |
| Irinotecan | Active comparator | Drug: Irinotecanirinotecan 180mg/m2 d1, q2w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
- Age 18 years or older
- Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
- Karnofsky performance status (KPS) of at least 70%
- Adequate renal function, adequate hepatic function, adequate bone marrow function
Key exclusion criteria (5 listed)
- The presence of any severe concomitant disease that could interrupt the planned treatment
- Intractable pain
- Hypersensitivity to study drugs
- Serious cardiovascular disease
- If female, pregnancy or breastfeeding
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 |
|---|---|---|
| Irinotecan | Drug | Irinotecan, Irinotecan and Capecitabine |
| Capecitabine | Drug | Irinotecan and Capecitabine |
Primary outcome
Progression Free Survival
Time frame: within 1 year
PFS
1 secondary outcome
Overall Survival
Time frame: within 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Irinotecan and Capecitabine in people with Biliary Tract Neoplasms, run by Zhejiang University 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 13 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: within 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 13 Feb 2018.