Clinical trial · Interventional
Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment
Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment: A Prospective, Multicenter, Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the efficacy and safety of surgical intervention in patients with focally progressive GISTs after imatinib treatment. The enrolled patients will be randomized to receive surgery following imatinib 400 milligram per day (MG/d) or only tyrosine kinase inhibitor (Imatinib 600 MG/d or Sunitinib 37.5 MG/d).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery following imatinib
- description
- Surgery requires at least removal of all drug-resistant lesions. Imatinib 400 MG/d should be taken once the patients resume oral diet.
- interventionNames
- Procedure: surgery
- Drug: Imatinib 400 MG
- type
- ACTIVE_COMPARATOR
- label
- Imatinib escalation or sunitinib
- description
- Escalation of imatinib or replacement of sunitinib are both conventional salvage treatments for imatinib-resistant GISTs. There is no high-level evidence to suggest which method is better. So patients are free to choose imatinib 600 MG/d or sunitinib 37.5 MG/d
- interventionNames
- Drug: Imatinib escalation
- Drug: Sunitinib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients whose pathology is clearly diagnosed as recurrent/metastatic GIST, have undergone standardized imatinib treatment, and the disease progresses during the treatment; 2. The lesions with progress are confined to one organ, and the number is ≤3; after evaluation by relevant professional surgeons or multidisciplinary team discussion, it is considered that the progressive lesions can be completely and safely removed without affecting the organ function; 3. Age: 18 years old ≤ age ≤ 75 years old; 4. No other malignant tumors occurred within five years; 5. Eastern Cooperative Oncology Group (ECOG) physical status score \<2 points; 6. American Society of Anesthesiologists (ASA) score \<3 points; 7. There are no restrictions on gender and race; 8. Patients with informed consent. Exclusion Criteria: 1. The patient has other serious comorbidities and cannot tolerate surgery: such as severe cardiopulmonary disease, cardiac function in grade 2 or lower, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (COPD), etc., combined with severe diabetes and/or kidney Insufficient function, combined with severe hepatitis and/or functional Child-pugh grade C or a grade B that is clearly difficult to correct, combined with severe malnutrition; 2. Patients with extensive disease progress; 3. Imatinib primary resistant patients; 4. Patients with other diseases requiring simultaneous surgical intervention, such as gallstones; inguinal hernia; 5. Disease-related complications such as bleeding, perforation, and obstruction; 6. Pregnant or lactating women; 7. The patient has a serious mental illness; 8. Patients with other malignant tumors within five years; 9. The patient has participated in or is participating in other clinical studies or is using other tyrosinekinase inhibitors.
References
Publications (0)
Data not yet available