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A single arm multicenter clinical study of miglitol in the treatment of muscle invasive bladder cancer

A single arm multicenter clinical study of miglitol in the treatment of muscle invasive bladder cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074474
Enrollment
Unknown
Registered
2023-08-08
Start date
2023-03-17
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Bladder cancer

Interventions

Experimental Group:Oral adminstration of Miglitol

Sponsors

South China Hospital of Shenzhen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 20-80 2) Pathological diagnosis of myometrial invasive bladder cancer (= T2) 3) The tumor invades the tissues around the bladder or adjacent organs (T3, T4) 4) Patients who require bladder preservation after full communication 5) Patients without indications for surgical treatment 6) After communication, they are willing to participate in the trial, promise to take medicine according to the doctor's instructions, and can follow up and communicate on time 7) No history of radiotherapy and chemotherapy, no history of other tumors

Exclusion criteria

Exclusion criteria: 1) Any of the following circumstances: people with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy; People suffering from fever and acute infectious diseases, including active tuberculosis, or those undergoing anti-tuberculosis treatment; Accompanied by severe chronic cardio-cerebrovascular disease or chronic kidney disease; 2) Those with other tumors; 3) Those who have received chemotherapy, radiotherapy and immunotherapy in the past 4 weeks (except for bladder infusion chemotherapy immediately after operation); 4) Bladder perforation is known or suspected during operation; 5) Patients with severe urethral stricture who cannot be placed cystoscope; 6) Pelvic CT or physical examination showed tumor metastasis; 7) Known to have low immune function, acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8) Those suffering from serious cardio-cerebrovascular diseases, such as myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism, who cannot tolerate TURBT surgery; 9) There are obvious main visceral organ dysfunction, such as creatinine>1.5 times the upper limit of the normal value range, AST, ALT, total bilirubin>1.5 times the upper limit of the normal value range, etc; 10) Subjects with fever and body temperature exceeding 38 ? and obvious active infection that can affect the clinical trial, such as acute pneumonia, active tuberculosis and severe urinary tract infection; 11) Known opioid or alcohol addicts; 12) Those who have obvious gastrointestinal reactions after taking Miglitol; 13) Patients with inflammatory bowel disease, colon ulcer, incomplete intestinal obstruction, and tendency of intestinal obstruction; Chronic intestinal disease is accompanied by obvious gastrointestinal dysfunction, or with patients who may further aggravate the occurrence of flatulence; 14) Diabetes ketoacidosis poisoning; 15) Those who are allergic to the drug or its ingredients; 16) The investigator believes that there may be any situation that increases the risk of the subject or interferes with the execution of the clinical trial.

Design outcomes

Primary

MeasureTime frame
Histopathological remission rate;

Secondary

MeasureTime frame
Image remission rate;

Countries

China

Contacts

Public ContactLi Yuqing

South China Hospital of Shenzhen University

liyu2t@163.com+86 136 3266 0500

Outcome results

None listed

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