Carcinoma, Transitional CellPhase 2NCT03051373
Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract
A Phase 2 study testing nanoparticle albumin-bound paclitaxel, S-1 and Gemcitabine, cisplatin in people with Carcinoma, Transitional Cell, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Transitional Cell
- What is being tested?
- nanoparticle albumin-bound paclitaxel, S-1 and Gemcitabine, cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed-consent form.
- Man or woman aged 18 years to 70 years.
- Histologically confirmed unresectable locally advanced or metastatic transitional cell carcinoma, occur in renal pelvis, ureter, urinary bladder or urethra: unresectable stage T3-4 tumor; lymph node metastasis; distance metastasis.
- Patients with mixed histology may be enrolled if the proportion of transitional cell carcinoma is the predominant component (> 50% of the histopathology sample).
- Patient without prior anticancer therapy, except for radical excision. Prior adjuvant therapy is allowed, only if the documented relapse intervention >12 months since completion of the last adjuvant therapy.
- At least one measurable tumor lesion (measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1), and the measurable tumor received no local therapy (e.g. radiotherapy or cryotherapy).
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- Eastern Cooperative Oncology Group (ECOG) 0-1, no progression within 2 weeks before enter into the trial, and with life expectation of no less than 12 weeks.
- Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.
Who cannot join
- Patients who accepted any therapy blow:
- Patients who received prior systemic therapy, including chemotherapy, biotherapy, immunotherapy or experimental therapy, but except for adjuvant and neoadjuvant therapy.
- Undergo major surgery (except for revascularization) within 4 weeks prior to the first dose.
- Undergo radiotherapy to more than 30% of marrow, or large field irradiation within 4 weeks prior to the first dose.
- Patients who were taking (or can't stop within 1 weeks prior to the first dose) any certain drug or herbal supplements, which was known to be the inhibitor or inducer of cytochrome P450 (CYP) 3A4.
- Other anticancer therapy.
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- The interval from the discontinuation of other investigational agent is less than 5 T1/2 of the drug.
- Patients were aware of receiving any similar therapy before.
- Concurrent or past history of another malignancy, need therapy within 2 years after the first dose.
- Any unresolved AE grade >1 (CTCAE) from previous systemic therapy (e.g. adjuvant chemotherapy) before entry the trial, except for alopecia and grade 2 neuropathy induced by former chemotherapy.
- Patients with symptomatic central nervous system (CNS) metastasis.
- Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, but not limited in HBV, HCV, or HIV.
- Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1.
- Patients have active cardiac disease including any of the following:
- In resting state, average correction QTc > 470 msec on mean value of 3 times screening ECGs, all data come from outpatient screening period.
- Any clinically significant abnormal ECG form, for example, complete left bundle branch block, 3-degree atrioventricular block, 2-degree atrioventricular block, or PR interval > 250 msec.
- Any factors may increase the risk of QTc prolongation or arrhythmic event.
- Marrow function abnormalities and organ dysfunction, reach any of the following laboratory values:
- ANC <1.5 x 109/L
- Platelets < 100 x 109/L
- Hemoglobin < 9.0 g/dL
- Alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) without liver metastases; or ALT > 5 x ULN, if liver metastases are present.
- Aspartate aminotransferase (AST) > 2.5 ULN, without liver metastases; or AST > 5 x ULN, if liver metastases are present.
- Serum total bilirubin > 1.5 x ULN without liver metastases; or total bilirubin > 3.0 x ULN in patients with well documented Gilbert syndrome or liver metastases.
- Serum creatinine > 1.5 x ULN with 24-hour clearance < 50 mL/min (measured values, or calculate by the Cockcroft-Gault formula) at the same time; only if creatinine > 1.5 x ULN, 24-hour clearance is needed to be confirmed.
- Patients who are unwilling or unable to abide by the study protocol, prohibition and requirement. Patient should not take part in the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited.
The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.
Read the detailed description
Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited.
The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.
- Conditions
- Carcinoma, Transitional Cell
- Being tested
- nanoparticle albumin-bound paclitaxel, S-1, Gemcitabine, cisplatin
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoparticle albumin-bound paclitaxel, S-1Drug
Also called nab-paclitaxel abraxane ABI-007
Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
Gemcitabine, cisplatinDrug
Also called GEMXAR
Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel plus S-1 | Experimental | Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles. Receives: Drug: nanoparticle albumin-bound paclitaxel, S-1 |
| Gemcitabine plus cisplatin | Active comparator | Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles. Receives: Drug: Gemcitabine, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measure the time of progression-free from start of treatment, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: up to 12 months
Secondary outcomes (4)
Overall response rate
The proportion of patients with a confirmed complete or partial response (CR or PR) according to RECIST v1.1. CR = disappearance of all target lesions. PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: every 2 cycles (6 weeks) until treatment discontinuation, an expected average of 1 year.
Disease control rate
Defined by RECIST criteria (version 1.1) as a percentage of best overall responses of CR+PR+SD.
Measured: change from baseline in tumor assessment at 18 weeks (cycle 6).
Overall survival
Measure of time from Day 1 of study drug administration to disease progression or death or lost to follow-up on study.
Measured: every 8 weeks until disease progression or death on study, an expected average of 2 years. Patients with progressive disease will be followed every 3 months for the first year and every 6 months thereafter up to 5 years.
The number of treatment-emergent adverse events (AEs) and serous adverse events (SAEs) as a measure of safety
The reported incidence of AEs and SAEs with an onset on or after the initiation of therapy will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Measured: every 3 weeks until treatment discontinuation plus 30 days, an expected average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Apr 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Transitional CellStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Yang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051373
- Sponsor's protocol ID
- BY-001
- Status last verified
- Aug 2021
- First submitted
- 9 Feb 2017
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract
- ClinicalTrials.gov ID
- NCT03051373
- Acronym / sponsor ID
- BY-001
- Conditions
- Carcinoma, Transitional Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 13 Feb 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.
Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited.
The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.
Detailed description
Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited.
The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel plus S-1 | Experimental | Drug: nanoparticle albumin-bound paclitaxel, S-1Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles. |
| Gemcitabine plus cisplatin | Active comparator | Drug: Gemcitabine, cisplatinGemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed-consent form.
- Man or woman aged 18 years to 70 years.
- Histologically confirmed unresectable locally advanced or metastatic transitional cell carcinoma, occur in renal pelvis, ureter, urinary bladder or urethra: unresectable stage T3-4 tumor; lymph node metastasis; distance metastasis.
- Patients with mixed histology may be enrolled if the proportion of transitional cell carcinoma is the predominant component (> 50% of the histopathology sample).
- Patient without prior anticancer therapy, except for radical excision. Prior adjuvant therapy is allowed, only if the documented relapse intervention >12 months since completion of the last adjuvant therapy.
Key exclusion criteria (26 listed)
- Patients who accepted any therapy blow:
- Concurrent or past history of another malignancy, need therapy within 2 years after the first dose.
- Any unresolved AE grade >1 (CTCAE) from previous systemic therapy (e.g. adjuvant chemotherapy) before entry the trial, except for alopecia and grade 2 neuropathy induced by former chemotherapy.
- Patients with symptomatic central nervous system (CNS) metastasis.
- Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, but not limited in HBV, HCV, or HIV.
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 |
|---|---|---|
| nanoparticle albumin-bound paclitaxel, S-1Also: nab-paclitaxel abraxane ABI-007Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles. | Drug | nab-paclitaxel plus S-1 |
| Gemcitabine, cisplatinAlso: GEMXARGemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles. | Drug | Gemcitabine plus cisplatin |
Primary outcome
Progression-free survival
Time frame: up to 12 months
Measure the time of progression-free from start of treatment, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
4 secondary outcomes
Overall response rate
Time frame: every 2 cycles (6 weeks) until treatment discontinuation, an expected average of 1 year.
Disease control rate
Time frame: change from baseline in tumor assessment at 18 weeks (cycle 6).
Overall survival
Time frame: every 8 weeks until disease progression or death on study, an expected average of 2 years. Patients with progressive disease will be followed every 3 months for the first year and every 6 months thereafter up to 5 years.
The number of treatment-emergent adverse events (AEs) and serous adverse events (SAEs) as a measure of safety
Time frame: every 3 weeks until treatment discontinuation plus 30 days, an expected average of 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 9 Aug 2021.
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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 nanoparticle albumin-bound paclitaxel, S-1 and Gemcitabine, cisplatin in people with Carcinoma, Transitional Cell, run by Chinese PLA General 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 9 inclusion and 26 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 9 Aug 2021. 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: up to 12 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 9 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.