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A prospective, single-arm, multi-center clinical study of adjuvant treatment of Gastrointestinal Stromal Tumors with Imatinib Mesylate (Gnical)

A prospective, single-arm, multi-center clinical study of adjuvant treatment of Gastrointestinal Stromal Tumors with Imatinib Mesylate (Gnical)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017181
Enrollment
Unknown
Registered
2018-07-17
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-23

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

Conditions

Gastrointestinal Stromal Tumors

Interventions

Case series:adjuvant Gastrointestinal Stromal Tumors after Imatinib Mesylate

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years male and female; 2. Gastrointestinal stromal tumor was confirmed by histopathological, and immunohistochemical detection of CD117 and / or DOG-1 was positive; 3. The types of gene mutiotion:exons 9 ,11 ,13 and 17 of the c-kit gene and exons 12 and 18 of the PDGFRA gene; 4. The lesions of Gastrointestinal Stromal Tumors have been completely resected (R0), and the risk grade is intermediate risk and high risk; 5. Physical condition was 0-2 points with ECOG; 6. The patient gaves informed consent and signs a written consent; 7. Patient compliance was good and voluntarily accepted follow-up, treatment, laboratory tests, and other research steps as planned.

Exclusion criteria

Exclusion criteria: 1. The PDGFRA gene exon 18 D842V mutation and the wild type GIST. 2. AST and / or ALT > 2.5 × ULN. 3. Serum total bilirubin > 1.5 x ULN. 4. The absolute count of neutrophils (ANC) is 1.0×ULN. 6. Past Medical History:Brain or pial disease such as brain metastasis, spinal cord compression, and cancerous meningitis and other malignant tumors. 7. Any of the following conditions within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, or cerebrovascular accident. 8. Serum HIV antibody was positive. 9. The patient is Currently participating in other clinical trials. 10. Women pregnant or lactating or have fertility but have not used contraception. 11. Patients with other serious acute or chronic physical or mental problems, or abnormal laboratory tests, may increase the risk of participating in the study or use of drugs, or interfere with the judgment of the results of the study, and the researcher judges that it is not suitable for participation in the study; 12. Treated with tyrosine kinase inhibitors including Imatinib Mesylate previously.

Design outcomes

Primary

MeasureTime frame
Tumor recurrence;

Countries

China

Contacts

Public ContactPeichun Sun

Henan Provincial People's Hospital

sunpeichun@126.com+86 13603450378

Outcome results

None listed

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