Clinical trial · Interventional
Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer
Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial
NCT07261592CI-TRIAL-00098291not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| Entinostat | — | UNRESOLVED | — |
| Histone Deacetylase Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Entinostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Entinostat plus chemotherapy
- description
- The study was divided into two phases: chemotherapy phase and continuous treatment phase. During chemotherapy phase, patients receive 6 cycles of GC (gemcitabine and cisplatin) chemotherapy along with entinostat followed by efficacy evaluation. If stable disease is reached according to RECIST 1.1 criteria, patients may receive continuous entinostat treatment until disease progression or intolerable side effects.
- interventionNames
- Drug: Entinostat
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Objective response rate, ORR
- timeFrame
- 36 months
- description
- ORR refers to the percentage of confirmed cases of complete response (CR) and partial response (PR) according to the RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both; * Failure of first-line treatment; * There is at least one measurable lesion according to RECIST 1.1; * Archived tumor tissue samples or tumor biopsies must be provided; * ECOG score of 0-1 an an estimated survival of at least 6 months; * Adequate organ function; * Patients voluntarily participated in this study, signed the informed consent form, and had good compliance; * Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug. Exclusion Criteria: * Patients who received platinum-based chemotherapy after failure of first-line treatment; * Patients who received platinum-based chemotherapy withnin a 24 month before this trial; * Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity); * Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina; * Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study; * Patients with serious physical or mental illnesses.
References
Publications (0)
Data not yet available
No reference posted for this study.