Adjuvant post-surgery therapy with imatinib in gastrointestinal stromal tumor patients with intermediate or high risk

Adjuvant post-surgery therapy with imatinib in gastrointestinal stromal tumor patients with intermediate or high risk:a single-centre, open-label, non-controlled study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TNC-09000582

Enrollment

Unknown

Registered

2009-11-11

Start date

2004-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Gastrointestinal stromal tumor

Interventions

Group A:Adjuvant therapy

Group B:Adjuvant therapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >18 years of age, male or female; 2. Pathologically confirmed negative surgical margins (R0) after resection; 3. Immunohistochemical staining showing CD117(+); 4. Intermediate or high risk of recurrence based on the 2001 NIH classification (largest tumor dimension >5 cm and/or mitotic count >5/50 high-power fields [HPFs]); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion criteria

Exclusion criteria: 1. Patients with severe hematologic disorder, severe renal, hepatic, cardiovascular or pulmonary function impairment; 2. Active infection requiring systemic antibiotics; 3. Pregnant or breast-feeding women.

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival;	—

Secondary

Measure	Time frame
Significance of exon 11 mutation in adjuvant therapy;	—

Countries

China

Contacts

Public ContactLin Shen

lin100@medmail.com.cn+86 010 88196175

Outcome results

None listed

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