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Miglitol combined with GC chemotherapy regimen to improve the efficacy of locally advanced and advanced bladder cancer

Miglitol combined with GC chemotherapy regimen to improve the efficacy of locally advanced and advanced bladder cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083579
Enrollment
Unknown
Registered
2024-04-28
Start date
2024-07-29
Completion date
Unknown
Last updated
2024-08-12

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, 50mg, three times a day, taken before meals.

Sponsors

South China Hospital of Shenzhen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: All enrolled subjects must meet all the following criteria: 1) Diagnosed unresectable local advanced or advanced bladder cancer; 2) Age not exceeding 75 years old; 3) ECOG score is 0-1; 4) Previously used a three cycle GC chemotherapy regimen, which was evaluated as SD by imaging, and it is not ruled out that ADC and immune checkpoint inhibitors have been used in combination; 5) After communication, subjects willing to participate in this study, promise to take the medication according to the doctor's advice, and can follow up and communicate on time.

Exclusion criteria

Exclusion criteria: Any candidate who meets any of the following criteria will not be eligible for inclusion in this study: 1) Any of the following states: people with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy; Individuals suffering from fever and acute infectious diseases, including active tuberculosis, or those undergoing anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; 2) Merge with other tumors; 3) Known to have low immune function, acquired or congenital immunodeficiency, or a history of organ transplantation; 4) Individuals with severe cardiovascular and cerebrovascular diseases, such as myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accidents or transient ischemic attacks, or pulmonary embolism, who cannot tolerate TURBT surgery; 5) There are obvious main visceral organ dysfunction, such as creatinine is more than 2 times of the upper limit of the normal range, AST, ALT, total bilirubin are more than 2 times of the upper limit of the normal range, etc; 6) Subjects with fever and body temperature exceeding 38 ?, significant active infections that can affect clinical trials, such as acute pneumonia, active tuberculosis, and severe urinary tract infections; 7) Patients with diabetes who need to take sulfonylurea drugs and insulin for a long time; 8) Individuals who are allergic to the drug or its ingredients; 9) The researchers believe that there may be any situation that increases the risk of subjects or interferes with the execution of clinical trials.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progression-Free Survival;Overall Survival;

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