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To Assess the Safety and Efficacy of Submucosal Injection by Gemcitabine Combined with Tumor Resection for Bladder Tumor

To Assess the Recurrence of Middle and High Risk NMIBC by Endoscopically Submucosal Injection by Gemcitabine Combined with Tumor Resection: A Prospective, Randomized Controlled, Single Center Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016297
Enrollment
Unknown
Registered
2018-05-24
Start date
2013-09-01
Completion date
Unknown
Last updated
2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer

Interventions

observation group:Submucosal Injection by Gemcitabine Combined with Tumor Resection
control group: Tumor Resection

Sponsors

The Affiliated Huai'an 1st People's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Middle and High Risk NMIBC: including Multiple, recurrent, urothelial carcinoma grade II-III, tumor >3cm, invasion of submucosa, or carcinoma in situ; (2) Aged 18 to 75 years; (3) The function of liver and kidney is normal; (4) ECOG: 0-1.

Exclusion criteria

Exclusion criteria: (1) liver (ALT>100 U/L) and renal insufficiency (glomerular filtration rate <50m1/min x kg), pulmonary dysfunction, heart failure, acute myocardial infarction, severe infection and trauma, major surgery, and clinical hypotension and hypoxia; (2) other clinical trials are being taken; (3) pregnant; (4) the combination of other malignant tumors; (5) bone marrow transplantation; (6) the absolute count of granulocytes should be no less than 1500 x 106/L, and the platelet count should reach 100 x 109/L.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;—

Countries

China

Contacts

Public ContactGuang-Bo Fu

The Affiliated Huai'an 1st People's Hospital of Nanjing Medical University

fgb200@vip.163.com+86 13951476053

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026