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Recruiting NCT06257017

Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma

Phase II Interventional Muscle Invasive Bladder Urothelial Carcinoma Muscle-Invasive Bladder Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: gemcitabine, Cisplatin.
Who it may be relevant to
Registry conditions: Muscle Invasive Bladder Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial

Overview

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.

Interventions

  • Drug gemcitabine
    1,000 mg/m2 intravenous gemcitabine on day 1 and day 8
  • Drug Cisplatin
    70 mg/m2 intravenous cisplatin (split into 2 doses on day 1 and day 8)

Primary outcome measures

  • the radiational disease-free survival (rDFS) [Time frame: 1 year]
Secondary outcome measures (3)
  • Progression Free Survival (PFS) [Time frame: 1 year]
  • Overall Survival (OS) [Time frame: 5 year]
  • ctDNA clearance rate in ctDNA(+) patients [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • aged 18-70 years old;
  • a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;
  • receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;
  • histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;
  • Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;
  • 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;
  • 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)
  • 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

  • receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;
  • participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;
  • suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;
  • conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) <50 mL/min, hearing impairment, and inadequate marrow function;
  • anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;
  • active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis;
  • pregnancy or breastfeeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Queen Mary Hospital — Hong Kong

Publications

  • Zhan Y, Ruan X, Wu Y, Chun TTS, Yao C, Shi R, Liu J, Ali S, Ma R, Huang D, Gao Y, Xu Y, Chen L, Du Q, Ng AT, Li CWB, Xu D, Na R. Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 26;14:e72597. doi: 10.2196/72597. PMID 40857715

Identifiers

NCT: NCT06257017 · HKURO202401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗