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The correlation between steady-state trough concentration distribution of imatinib and efficacy/safety in Chinese population: a retrospective cohort study

The correlation between steady-state trough concentration distribution of imatinib and efficacy/safety in Chinese population: a retrospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079985
Enrollment
Unknown
Registered
2024-01-17
Start date
2024-01-17
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Gastrointestinal stromal tumor

Interventions

Imatinib treatment group:NA

Sponsors

Harbin Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years old, diagnosed as gastrointestinal stromal tumor through pathological histology and immunohistochemical examination. 2. Take imatinib continuously and regularly for more than a month, and follow the doctor's advice daily without any missed medication, and achieve a stable blood drug concentration. 3. Those with complete clinical data and complete follow-up information shall undergo clinical follow-up on time. 4. Signed an informed consent form and conducted regular outpatient follow-up. 5. The treatment compliance is good, and there are no serious diseases in other important organs.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, patients with extremely poor mental and physical conditions; 2. Oral administration of imatinib mesylate is less than one month, and the expected overall survival period is less than three months; 3. Simultaneously taking other targeted drugs while taking imatinib mesylate; 4. Individuals with a history of mental illness or symptoms of abnormal mental state; 5. Patients who experience imatinib resistance or treatment intolerance and terminate treatment; 6. Individuals who have participated in clinical trials of other drugs for the past three months or are currently participating in such trials; Simultaneously taking CYP3A4 inducers or inhibitors; Common CYP3A4 inducers include rifampicin, rifampicin, phenytoin, carbamazepine, barbiturates, or St. John's wort. Common CYP3A4 inhibitors include itraconazole, ketoconazole, voriconazole, azavir, ritonavir, clarithromycin, grapefruit, etc.

Design outcomes

Primary

MeasureTime frame
Distribution of steady-state trough concentration after treatment with imatinib 400mg/d;The correlation between steady-state trough concentration distribution of imatinib and efficacy/safety in Chinese population;

Secondary

MeasureTime frame
objective response rate;Disease control rate;progression-free survival;overall survival;safety;

Countries

China

Contacts

Public ContactMei Dong

Harbin Medical University Cancer Hospital

122174817@qq.com+86 451 8629 8399

Outcome results

None listed

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