Bladder Cancer Stage IVPhase 2NCT04562311
Chidamide With Immunotherapy for Patients With Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 2 study testing Chidamide in people with Bladder Cancer Stage IV, run by Sun Yat-sen University at 1 site in China.
Trial summary
Study of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer Stage IV
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 18 Aug 2026
- 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
- 1.Age ≥18 years, < 75 years
- 2.Histopathological diagnosis of transitional cell carcinoma or urothelial carcinoma; It may be associated with other cell types such as small cell carcinoma, neuroendocrine carcinoma or squamous cell carcinoma, but the component should be mainly urothelial carcinoma
- 3.Patients with advanced urothelial carcinoma (inoperable or metastatic to lymph nodes or distant metastases) recurred or progressed during adjuvant therapy or advanced first-line platinum-based chemotherapy; Patients receiving secondary chemotherapy may be included, but more than 12 months from the end of the first chemotherapy to the beginning of the second chemotherapy; Subjects who receive neoadjuvant chemotherapy or adjuvant chemotherapy and who develop disease progression within 12 months of the last dose are considered to be receiving systemic chemotherapy in the context of cancer metastasis (disease progression is defined as any progression requiring a change in treatment regimen prior to treatment)
- 4.Measurable target lesion (without radiotherapy) : defined as having at least one lesion that can be accurately measured in at least one dimension (the longest diameter recorded), such as ≥15mm conventional technique or ≥10mm helical CT scan; Patients with bone metastases may also participate in the study, provided they also have a measurable non-osseous disease
- 5.Life expectancy is more than 3 months
- 6.ECOG performance status 0~2 (Karnofsky >= 60%)
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- 7.Bone marrow, liver and renal function adequate: Blood routine examination: neutrophil count ≥2.0×109/L, PLT count ≥75×109/L, WBC count ≥3.0×109/L, hemoglobin concentration ≥90.0g/dL; Liver function: AST and ALT≤1.5 times the upper limit of normal value (ULN), alkaline phosphatase ≤1.5×ULN, TBIL≤ULN; Cr 1.5 x ULN or less
- 8.Left ejection fraction (LVEF) ≥50%, electrocardiogram (ECG) was generally normal, QTc interphase <0.44 seconds, and there were no signs or symptoms of heart failure
- 9. Acute toxicity caused by previous treatment is alleviated to level ≤1 (except hair loss)
- 10.The eligibility of patients receiving any drug or substance known or likely to affect cedaramide activity or pharmacokinetics will be determined after review by the principal investigator for a period of more than 6 weeks
- 11.Understand and be willing to sign written informed consent documents
Who cannot join
- 1.Patients who received chemotherapy (nitrosourea or mitomycin C for 6 weeks) within 4 weeks before the study began, or who did not recover from adverse events due to drug use more than 4 weeks in advance
- 2.Patients shall not receive any other anticancer drugs or clinical trial drugs during the clinical trial period (local palliative radiotherapy other than the target lesion may be accepted)
- 3.Patients with brain metastases
- 4.A history of allergic reactions to compounds that are chemically or biologically similar to cedarbenamine; These compounds include sodium butyrate, Trichostatin A (TSA), Trapoxin (TPX), MS-27-275, and Depsipeptide
- 5.Treatment of Urothelial carcinoma with more than two lines or above cytotoxic chemotherapy regiments
- 6.Uncontrolled underlying concomitant diseases, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric/social conditions, may limit compliance with study requirements
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- 7.Pregnant women are excluded and should stop breastfeeding if they receive treatment during lactation in the study
- 8.Long-term use of immunosuppressive agents after organ transplantation; Patients with autoimmune diseases; Patients who are taking immunosuppressive drugs
- 9.HIV positive or have other immunodeficiency diseases
- 10.Combined with other active malignancies (i.e., changes in treatment required within the past 24 months). Only patients with skin cancer that has been treated within the past 24 months and has been completely cured are allowed to be enrolled. Localized prostate cancer with Gleason score of 6 (treated or untreated but monitored within the past 24 months); Localized prostate cancer with a Gleason score of 3+4 that was treated more than 12 months prior to full study screening and was completely cured
- 11.Live virus vaccine is administered within 30 days of initial administration
- 12.Patients should not take valproic acid for at least 2 weeks before entering the study
- 13.Due to psychological, social, family, geographical and other reasons can not cooperate with regular follow-up observers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy:An Open, One-arm, Phase II Study
Study of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy
Read the detailed description
Chidamide has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China (Chidamide,a novel histone deacetylase inhibitor). Tirelizumab,has been approved for the failure treatment of platinum-containing chemotherapy with high PD-L1 expression included locally advanced or metastatic Urothelial carcinoma in China(Tirelizumab,BGB-A317 is an investigational humanized IgG4 anti-PD-1 monoclonal antibody ).The aim of this study was to observe the efficacy and safety of Chidamide with Immunotherapy in patients with progression of platinum-based chemotherapy recurrent and metastatic Urothelial carcinoma.
- Conditions
- Bladder Cancer Stage IV
- Being tested
- Chidamide
- Keywords
- Chidamide、Immunotherapy、Bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called Single-arm
Tucidinostat (Chidamide): 30mg orally BIW. Immunotherapy: tislelizumab,the fixed dose of 200 mg IV. Treatment cycles are repeated every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat (Chidamide) with Immunotherapy | Experimental | Tucidinostat (Chidamide): 30mg orally BIW. Immunotherapy: tislelizumab,the fixed dose of 200 mg IV. Treatment cycles are repeated every 3 weeks. Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
Measured: up to 2 years
Secondary outcomes (3)
Disease Control Rate （DCR）
the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）
Measured: up to 2 years
Progression-free survival(PFS)
Time from treatment until disease progression or death
Measured: up to 2 years
Overall survival(OS)
Time from treatment until death from any cause
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Jan 2021
- Primary completion30 Aug 2024
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder Cancer Stage IVStudies 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Jianfang Zhou, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562311
- Sponsor's protocol ID
- B2020-192-01
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi Y, Jia B, Xu W, Li W, Liu T, Liu P, Zhao W, Zhang H, Sun X, Yang H, Zhang X, Jin J, Jin Z, Li Z, Qiu L, Dong M, Huang X, Luo Y, Wang X, Wang X, Wu J, Xu J, Yi P, Zhou J, He H, Liu L, Shen J, Tang X, Wang J, Yang J, Zeng Q, Zhang Z, Cai Z, Chen X, Ding K, Hou M, Huang H, Li X, Liang R, Liu Q, Song Y, Su H, Gao Y, Liu L, Luo J, Su L, Sun Z, Tan H, Wang H, Wang J, Wang S, Zhang H, Zhang X, Zhou D, Bai O, Wu G, Zhang L, Zhang Y. Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China. J Hematol Oncol. 2017 Mar 15;10(1):69. doi: 10.1186/s13045-017-0439-6.
PubMed 28298231Li Y, Chen K, Zhou Y, Xiao Y, Deng M, Jiang Z, Ye W, Wang X, Wei X, Li J, Liang J, Zheng Z, Yao Y, Wang W, Li P, Xu B. A New Strategy to Target Acute Myeloid Leukemia Stem and Progenitor Cells Using Chidamide, a Histone Deacetylase Inhibitor. Curr Cancer Drug Targets. 2015;15(6):493-503. doi: 10.2174/156800961506150805153230.
PubMed 26282548Zhang L, Han Y, Jiang Q, Wang C, Chen X, Li X, Xu F, Jiang Y, Wang Q, Xu W. Trend of histone deacetylase inhibitors in cancer therapy: isoform selectivity or multitargeted strategy. Med Res Rev. 2015 Jan;35(1):63-84. doi: 10.1002/med.21320. Epub 2014 Apr 29.
PubMed 24782318Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Poehlein CH, Perini RF, Bajorin DF; KEYNOTE-045 Investigators. Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med. 2017 Mar 16;376(11):1015-1026. doi: 10.1056/NEJMoa1613683. Epub 2017 Feb 17.
PubMed 28212060
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy:An Open, One-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT04562311
- Acronym / sponsor ID
- B2020-192-01
- Conditions
- Bladder Cancer Stage IV
- Keywords
- Chidamide、Immunotherapy、Bladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 24 Sep 2020 (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.
Study of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy
Detailed description
Chidamide has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China (Chidamide,a novel histone deacetylase inhibitor). Tirelizumab,has been approved for the failure treatment of platinum-containing chemotherapy with high PD-L1 expression included locally advanced or metastatic Urothelial carcinoma in China(Tirelizumab,BGB-A317 is an investigational humanized IgG4 anti-PD-1 monoclonal antibody ).The aim of this study was to observe the efficacy and safety of Chidamide with Immunotherapy in patients with progression of platinum-based chemotherapy recurrent and metastatic Urothelial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat (Chidamide) with Immunotherapy | Experimental | Drug: ChidamideTucidinostat (Chidamide): 30mg orally BIW. Immunotherapy: tislelizumab,the fixed dose of 200 mg IV. Treatment cycles are repeated every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1.Age ≥18 years, < 75 years
- 2.Histopathological diagnosis of transitional cell carcinoma or urothelial carcinoma; It may be associated with other cell types such as small cell carcinoma, neuroendocrine carcinoma or squamous cell carcinoma, but the component should be mainly urothelial carcinoma
- 3.Patients with advanced urothelial carcinoma (inoperable or metastatic to lymph nodes or distant metastases) recurred or progressed during adjuvant therapy or advanced first-line platinum-based chemotherapy; Patients receiving secondary chemotherapy may be included, but more than 12 months from the end of the first chemotherapy to the beginning of the second chemotherapy; Subjects who receive neoadjuvant chemotherapy or adjuvant chemotherapy and who develop disease progression within 12 months of the last dose are considered to be receiving systemic chemotherapy in the context of cancer metastasis (disease progression is defined as any progression requiring a change in treatment regimen prior to treatment)
- 4.Measurable target lesion (without radiotherapy) : defined as having at least one lesion that can be accurately measured in at least one dimension (the longest diameter recorded), such as ≥15mm conventional technique or ≥10mm helical CT scan; Patients with bone metastases may also participate in the study, provided they also have a measurable non-osseous disease
- 5.Life expectancy is more than 3 months
Key exclusion criteria (13 listed)
- 1.Patients who received chemotherapy (nitrosourea or mitomycin C for 6 weeks) within 4 weeks before the study began, or who did not recover from adverse events due to drug use more than 4 weeks in advance
- 2.Patients shall not receive any other anticancer drugs or clinical trial drugs during the clinical trial period (local palliative radiotherapy other than the target lesion may be accepted)
- 3.Patients with brain metastases
- 4.A history of allergic reactions to compounds that are chemically or biologically similar to cedarbenamine; These compounds include sodium butyrate, Trichostatin A (TSA), Trapoxin (TPX), MS-27-275, and Depsipeptide
- 5.Treatment of Urothelial carcinoma with more than two lines or above cytotoxic chemotherapy regiments
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 |
|---|---|---|
| ChidamideAlso: Single-armTucidinostat (Chidamide): 30mg orally BIW. Immunotherapy: tislelizumab,the fixed dose of 200 mg IV. Treatment cycles are repeated every 3 weeks. | Drug | Tucidinostat (Chidamide) with Immunotherapy |
Primary outcome
Objective Response Rate（ORR）
Time frame: up to 2 years
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
3 secondary outcomes
Disease Control Rate （DCR）
Time frame: up to 2 years
Progression-free survival(PFS)
Time frame: up to 2 years
Overall survival(OS)
Time frame: up to 2 years
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 30 Oct 2026.
- Background: PubMed 28298231Shi Y, Jia B, Xu W, Li W, Liu T, Liu P, Zhao W, Zhang H, Sun X, Yang H, Zhang X, Jin J, Jin Z, Li Z, Qiu L, Dong M, Huang X, Luo Y, Wang X, Wang X, Wu J, Xu J, Yi P, Zhou J, He H, Liu L, Shen J, Tang X, Wang J, Yang J, Zeng Q, Zhang Z, Cai Z, Chen X, Ding K, Hou M, Huang H, Li X, Liang R, Liu Q, Song Y, Su H, Gao Y, Liu L, Luo J, Su L, Sun Z, Tan H, Wang H, Wang J, Wang S, Zhang H, Zhang X, Zhou D, Bai O, Wu G, Zhang L, Zhang Y. Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China. J Hematol Oncol. 2017 Mar 15;10(1):69. doi: 10.1186/s13045-017-0439-6.
- Background: PubMed 26282548Li Y, Chen K, Zhou Y, Xiao Y, Deng M, Jiang Z, Ye W, Wang X, Wei X, Li J, Liang J, Zheng Z, Yao Y, Wang W, Li P, Xu B. A New Strategy to Target Acute Myeloid Leukemia Stem and Progenitor Cells Using Chidamide, a Histone Deacetylase Inhibitor. Curr Cancer Drug Targets. 2015;15(6):493-503. doi: 10.2174/156800961506150805153230.
- Background: PubMed 24782318Zhang L, Han Y, Jiang Q, Wang C, Chen X, Li X, Xu F, Jiang Y, Wang Q, Xu W. Trend of histone deacetylase inhibitors in cancer therapy: isoform selectivity or multitargeted strategy. Med Res Rev. 2015 Jan;35(1):63-84. doi: 10.1002/med.21320. Epub 2014 Apr 29.
- Background: PubMed 28212060Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Poehlein CH, Perini RF, Bajorin DF; KEYNOTE-045 Investigators. Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med. 2017 Mar 16;376(11):1015-1026. doi: 10.1056/NEJMoa1613683. Epub 2017 Feb 17.
- 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.
Jianfang Zhou study chair
Sun Yat-sen University
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 Chidamide in people with Bladder Cancer Stage IV, run by Sun Yat-sen 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 11 inclusion and 13 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 30 Oct 2026. 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?
Objective Response Rate（ORR） (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562311, which also lists 4 linked publications.
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 30 Oct 2026.