This is a prospective, multicenter, observational real-world study to explore the therapy patterns and clinical outcomes of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors.
Patients who are aged ≥ 18 years.
Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and/or DOG-1-positive by immunohistochemistry.
Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness).
Treatment with Avapritinib.
KIT or PDGFRA wild type.
Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression.
Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the investigator.
Approximately 74 patients with metastatic or unresectable advanced gastrointestinal stromal tumors from tier-3 hospitals who meet the criteria will be enrolled in the study.
Case-only
Prospective
Not listed
Objective Response Rate
To evaluate objective response rate (ORR,CR+PR) determined by radiology assessment per mRECIST(Response Evaluation Criteriain Solid Tumours), version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.
Clinical Benefit Rate
To evaluate clinical benefit rate(CBR,CR+PR+\>16 weeks continuation SD) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.
Duration Of Response
To evaluate duration of response (DOR) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.If a lesion reappears after disappearing in a patient with complete response, progressive disease is declared. However, if such a lesion behaves in this manner in a patient with stable disease or partial response, it is the change in sum of target disease that defines the response or progression.
Progression-free survival
To evaluate PFS determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.If a lesion reappears after disappearing in a patient with complete response, progressive disease is declared. However, if such a lesion behaves in this manner in a patient with stable disease or partial response, it is the change in sum of target disease that defines the response or progression.
overall survival
To evaluate OS determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.If a lesion reappears after disappearing in a patient with complete response, progressive disease is declared. However, if such a lesion behaves in this manner in a patient with stable disease or partial response, it is the change in sum of target disease that defines the response or progression.
Treatment-emergent adverse events
To evaluate treatment-emergent adverse events determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.
adverse events of special interest
To evaluate adverse events of special interest determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.
resistance gene mutation status
Analysis of resistance gene mutation status in the treated population verse before the treatment by gene testing.
Assessment of dose effect of antineoplastic agents
The clinical effects of anti-tumor drugs in the treated population were assessed by monitoring according to the pharmacokinetic indicators mentioned above.
Click on the lead sponsor to view all of their trials.
Xinhua Zhang, MD
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Sponsor institution
Peking University Cancer Hospital & Institute
Collaborator
Fudan University
Collaborator
Peking University People's Hospital
Collaborator
Chinese PLA General Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Peking University Shenzhen Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
West China Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Xijing Hospital
Collaborator
Shengjing Hospital
Collaborator
Shanghai Jiao Tong University School of Medicine
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Chongqing University Cancer Hospital
Collaborator
