Clinical trial · Interventional
Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer - A Single-center, Single-arm and Stage II Clinical Study
NCT04060459CI-TRIAL-00040113unknownPhase 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 is a phase II study of Paclitaxel-binding albumin, Cisplatin as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel-binding albumin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment plan
- description
- Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt
- interventionNames
- Drug: Paclitaxel-binding albumin
Primary outcomes (1)
- measure
- The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
- timeFrame
- 2 years
- description
- Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Secondary outcomes (1)
- measure
- The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients must have histologically confirmed resectable（stage T2，T3 and T4a） urothelial carcinoma following 2017 V8 AJCC，including renal pelvic carcinoma，ureteral carcinoma，bladder carcinoma and urethral carcinoma. 3. There was at least one measurable tumor lesion following RECIST 1.1. 4. Treatment naïve. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. Left ventricular ejection fraction≥50%. 7. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L，platelets (PLT) ≥ 100 × 109/L，hemoglobin (Hb) ≥ 90 g/L，leucocyte ≥ 3.0 × 109/L. 8. Total bilirubin (TBIL) ≤ 1.5 ×institutional upper limit of normal (ULN)， Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) /Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]≤ 2.5 ×ULN ，Creatinine (CRE) ≤ 1.5 ×ULN. 9. Signed informed content obtained prior to treatment. Exclusion Criteria: 1. Patients who are pregnant or may be pregnant or nursing. 2. Patients with Coagulation dysfunction or active internal hemorrhage. 3. Patients with uncontrolled active infection，HIV，viral hepatitis. 4. Peripheral nerve lesion≥grade 1 following NCI-CTC 5.0. 5. Patients with serious cardiovasculardisease including history of cerebral vascular accident ， myocardial infarction，hypertension，angina，heart failure（NYHA grade 2-4） within the last 6 months. 6. History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study. 7. Patients was involved in another study within the last 30 days. 8. Patients was mental disorders. 9. Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.