Bladder Cancer, Chemotherapy, Entinostat, Histone Deacetylase Inhibitor
Conditions
Brief summary
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.
Interventions
DRUGEntinostat
Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).
DRUGChemotherapy
Gisantinib and cisplatin chemotherapy for 6 cycles, 21 days per cycle. Gisantinib 1000mg/m2 is given intravenously on Day 1 and 8 for each cycle while cisplatin 70mg/m2 is given intravenously on Day2.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate, ORR | 36 months | 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
| Measure | Time frame | Description |
|---|---|---|
| ProgressionFree Survival, PFS | 36 months | PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first). |
| Overall Survival, OS | 36 months | OS refers to the time from the beginning of treatment to death from any reason. |
| Disease Control Rate, DCR | 36 months | The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy. |
Countries
China
Contacts
Backup ContactHongqian Guo, PhD
Primary ContactJunlong Zhuang, PhD
Outcome results
None listed