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Role of surgery in patients with focally progressive GISTs after imatinib treatment: a prospective, multicenter, registration study

Role of surgery in patients with focally progressive GISTs after imatinib treatment: a prospective, multicenter, registration study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029913
Enrollment
Unknown
Registered
2020-02-16
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

Gastrointestinal stromal tumor

Interventions

One:Surgery + Imatinib400mg/d
Two:imatinib 600mg/d or sunitinib 37.5mg/d

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with recurrent/metastatic GIST were clearly diagnosed by pathology and had undergone standardized IM treatment, during which the disease progressed; 2. Progressive lesions are limited to one organ and the number is <=3; After evaluation by the relevant surgical experts or MDT discussion, it was considered that the progressive lesion could be safely removed completely without significant influence on organ function. 3. Aged 18-75 years; 4. No other malignant tumors occurred within five years; 5. ECOG physical status score of patients <2, ASA score <3; 6. There are no restrictions on gender or race; 7. Informed consent of patients.

Exclusion criteria

Exclusion criteria: 1. There are other serious complications, the patient can not tolerate surgery, such as with severe lung disease, cardiac function in clinical grading below level 2, pulmonary infection, moderately severe COPD, chronic bronchitis, etc, severe diabetes and/or renal dysfunction, and severe hepatitis and/or functional Child - pugh, class C and symptoms is difficult to correct(class B), and severe malnutrition, etc; 2. Patients with IM primary drug resistance; 3. Bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery; 4. Pregnant or nursing women; 5. The patients suffer from serious mental illness; 6. Patients with other malignant tumors within five years; 7. The patients have participated in or are participating in other clinical studies, or are using other TKI preparations;

Design outcomes

Primary

MeasureTime frame
One year progression-free survival;

Secondary

MeasureTime frame
one year overall survival;Incidence of adverse events;quality of life;

Countries

China

Contacts

Public ContactShen Kuntang

Zhongshan hospital affiliated to Fudan university

shen.kuntang@zs-hospital.sh.cn+86 13916146469

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 25, 2026