Muscle-Invasive Bladder Carcinoma Clinical Trial
Official title:
Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial
Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 30, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. aged 18-70 years old; 2. a score of =1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status; 3. receiving radical cystectomy (with lymph node dissection) or nephroureterectomy; 4. histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma; 5. Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0; 6. absence of microscopic (i.e., positive margin) or gross residual of the tumor (R0 resection) and absence of metastasis, confirmed by a negative CT or MRI scan of pelvis, abdomen and chest within 4 weeks prior to enrolment; 7. adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment: - ANC=1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1) - WBC counts > 2500 cells/µL - Lymphocyte count = 300 cells/µL - Platelet count = 100,000 cells/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1) - Hemoglobin = 9.0 g/dL - AST, ALT, and alkaline phosphatase = 2.5 × the upper limit of normal (ULN), - PTT = 1.5 × ULN - PT = 1.5 × ULN or INR < 1.7 - Calculated creatinine clearance = 30 mL/min (Cockcroft-Gault formula) 8. able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent Exclusion Criteria: 1. receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment; 2. participation in another clinical trial with therapeutic intent within 28 days prior to enrolment; 3. suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment; 4. conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) <50 mL/min, hearing impairment, and inadequate marrow function; 5. anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine; 6. active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis; 7. pregnancy or breastfeeding. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Yung NA | Pamela Youde Nethersole Eastern Hospital, Queen Mary Hospital, Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the radiational disease-free survival (rDFS) | 1 year | ||
Secondary | Progression Free Survival (PFS) | time to recurrence | 1 year | |
Secondary | Overall Survival (OS) | 5 year | ||
Secondary | ctDNA clearance rate in ctDNA(+) patients | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05097404 -
Clinical Utility of VI-RADS in Diagnosis of MIBC
|
||
Recruiting |
NCT05483868 -
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
|
Phase 1 | |
Not yet recruiting |
NCT04966130 -
Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
|
||
Active, not recruiting |
NCT04610671 -
Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC
|
Phase 1 | |
Recruiting |
NCT06341400 -
RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT06190197 -
Prophylactic Antibiotics in Cystectomy With Diversion
|
Early Phase 1 | |
Recruiting |
NCT05203913 -
Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer
|
Phase 2 | |
Recruiting |
NCT05790850 -
Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
|
N/A | |
Recruiting |
NCT05833867 -
Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
|
Phase 1 | |
Recruiting |
NCT05295992 -
Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
|
N/A | |
Recruiting |
NCT06215976 -
The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
|
Phase 4 | |
Recruiting |
NCT05028660 -
AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study
|
||
Not yet recruiting |
NCT06417190 -
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
|
Phase 2 | |
Not yet recruiting |
NCT04909775 -
Chemotherapy Combined With Tislelizumab as Bladder Sparing Option for Patients With Muscle Invasive Bladder Cancer
|
Phase 2 | |
Recruiting |
NCT04876313 -
An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo)
|
Phase 2 | |
Not yet recruiting |
NCT04686149 -
a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients
|
||
Active, not recruiting |
NCT05630131 -
ctDNA in Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy
|
||
Recruiting |
NCT06170177 -
Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
|
||
Terminated |
NCT05221827 -
Clinical Performance Evaluation of the C2i-Test
|
||
Recruiting |
NCT05767528 -
Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection
|