CholangiocarcinomaPhase 2NCT01963325
S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
A Phase 2 study testing S-1 plus Abraxane in people with Cholangiocarcinoma, run by Yuhong Li at 1 site in China.
Trial summary
This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- S-1 plus Abraxane
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to 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
- Histologic or cytologic diagnosis of cholangiocarcinoma
- Not eligible for curative surgery
- Progressed after first-line gemcitabine-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
- No serious or uncontrolled concomitant medical illness
- Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method).
Who cannot join
- Uncontrolled infection or severe active comorbid disease
- Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
- Pregnancy or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma
This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.
Read the detailed description
There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and safe in treating cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma
- Being tested
- S-1 plus Abraxane
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 plus AbraxaneDrug
Also called Paclitaxel Albumin-Bound Particles for Injectable Suspension, Gimeraciland Oteracil Porassium Capsules
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
| Study group | Role | What they receive |
|---|---|---|
| S-1 plus Abraxane | Experimental | Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment. Receives: Drug: S-1 plus Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates
Measured: 6 months
Secondary outcomes (2)
Progression-free survival
Measured: 6 months
Number of participants with adverse events
Adverse events evaluated by Common Terminology Criteria for Adverse Events v3.0.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuhong Li, Sun Yat-sen University
- Investigators
- Yuhong Li, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963325
- Sponsor's protocol ID
- S1vsNab-P20130819
- Status last verified
- Feb 2018
- First submitted
- 26 Sep 2013
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT01963325
- Acronym / sponsor ID
- S1vsNab-P20130819
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yuhong LiUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Oct 2013 (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 phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.
Detailed description
There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and safe in treating cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1 plus Abraxane | Experimental | Drug: S-1 plus AbraxanePatients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologic or cytologic diagnosis of cholangiocarcinoma
- Not eligible for curative surgery
- Progressed after first-line gemcitabine-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
- No serious or uncontrolled concomitant medical illness
Key exclusion criteria (3 listed)
- Uncontrolled infection or severe active comorbid disease
- Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
- Pregnancy or lactating women
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 |
|---|---|---|
| S-1 plus AbraxaneAlso: Paclitaxel Albumin-Bound Particles for Injectable Suspension, Gimeraciland Oteracil Porassium CapsulesPatients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment. | Drug | S-1 plus Abraxane |
Primary outcome
Response rates
Time frame: 6 months
2 secondary outcomes
Progression-free survival
Time frame: 6 months
Number of participants with adverse events
Time frame: 12 months
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 5 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.
Yuhong Li, MD principal investigator
Sun Yat-Sen University Cancer Center
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 S-1 plus Abraxane in people with Cholangiocarcinoma, run by Yuhong Li 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 6 inclusion and 3 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 5 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?
Response rates (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 5 Feb 2018.