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Safety and Efficacy of Neoadjuvant Imatinib Therapy in Locally Advanced Gastric Gastrointestinal Stromal Tumors: A Prospective, Multicenter, Real-World Study

Safety and Efficacy of Neoadjuvant Imatinib Therapy in Locally Advanced Gastric Gastrointestinal Stromal Tumors: A Prospective, Multicenter, Real-World Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107981
Enrollment
Unknown
Registered
2025-08-21
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

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 Neoadjuvant Therapy Group for Locally Advanced Gastric Gastrointestinal Stromal Tumors:None

Sponsors

Zhongshan Hospital, Fudan University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients pathologically diagnosed with gastric-origin gastrointestinal stromal tumors (GISTs); 2. Age between 18 and 75 years (inclusive); 3. Gastric GISTs larger than 10 cm, or larger than 5 cm located at anatomically challenging gastric sites, which are technically resectable but may compromise organ function; 4. Eastern Cooperative Oncology Group (ECOG) performance status <2 and American Society of Anesthesiologists (ASA) score <3; 5. No other severe comorbidities or conditions that could interfere with efficacy evaluation; 6. Written informed consent obtained from the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Patients with severe comorbidities who are unable to tolerate surgery, such as significant cardiopulmonary diseases (e.g., NYHA class > II heart failure, pulmonary infection, moderate to severe COPD, chronic bronchitis), poorly controlled diabetes and/or renal insufficiency, severe hepatitis and/or liver dysfunction classified as Child-Pugh class C or symptomatic and difficult-to-correct class B, severe malnutrition, etc.; 2. Patients with severe psychiatric disorders; 3. Patients with a history of other malignancies within the past five years; 4. Patients previously treated with other tyrosine kinase inhibitors (TKIs); 5. Patients with disease-related complications such as bleeding, perforation, or obstruction; 6. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Pathological complete response rate;Objective Response Rate;

Secondary

MeasureTime frame
Recurrence-Free Survival;Overall Survival;

Countries

China

Contacts

Public ContactShen Kuntang

Zhongshan Hospital, Fudan University School of Medicine

shen.kuntang@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

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