Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hy… (NCT04490993) | Clinical Trial Compass
UnknownPhase 3
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
China359 participantsStarted 2017-03-30
Plain-language summary
To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive bladder cancer (NMIBC) patients
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must be informed of the investigational nature of this study and must provide written informed consent
* Age ≥18 years, male or female
* Must have clinically and histologically confirmed recurrent intermediate and high-risk non-muscle invasive transitional cell carcinoma of the bladder after treatment with intravesical chemotherapy. EORTC risk score (according to EUA "NMIBC Guideline" 2015 version) must be ≥ 5: Papilloma alone (or with Cis) or Cis alone No visible tumor after TURBT on tumor lesion
* Medical history of intravesical chemotherapy Subjects who received intravesical chemotherapy prior to enrollment, but didn't receive BCG or other intravesical therapy with immune drugs Subjected who are refractory to the recommended intravesical chemotherapy drugs pirarubicin, epirubicin, doxorubicin, hydroxy camptothecin, mitomycin, or gemcitabine (according to "Guideline of Diagnosis and Treatment of Urological Diseases in China", 2014 version)
* Re-TURBT:
For subjects undergoing secondary TURBT, EORTC risk score must be ≥ 5, which can be assessed based on the results of any TURBTs. The other results will be based on first TURBT For subjects undergoing secondary TURBT, the enrollment time will start from the second TURBT It is recommended to conduct the secondary TURBT under following situations: incomplete first TURBT; no muscle tissue found in the first TURBT specimen, except Ta G1 (low grade) tumor and CIS only; T1 tumor; G3 (high grade) tumor (except …