A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors

NCT05464875 | Recruiting DMC

• 1 other identifier: No.[2022]106
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Stromal Tumors; Unresectable Solid Tumor; Recurrent Metastatic Malignant Neoplasm

Keywords

Avapritinib; Genetic testing

Outcome Measures

Primary Outcomes (3)

• 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.

  2 years

• 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.

  2 years

• 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.

  2 years

Secondary Outcomes (13)

• Progression-free survival

  2 years

• overall survival

  2 years

• Treatment-emergent adverse events

  2 years

• adverse events of special interest

  2 years

• serious adverse events

  2 years

Other Outcomes (2)

• resistance gene mutation status

  2 years

• Assessment of dose effect of antineoplastic agents

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.
• Patient informed consent and signed written consent form.
• The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Zhang, MD: lead
• 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: 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

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080, China

RECRUITING

Related Publications (19)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xinhua Zhang, PhD

  First affiliated hosptial,Sun Yat-sen university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinhua Zhang, PhD

CONTACT

+8620-87332200; zhangxinhua@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: First Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 19, 2022
• Study Start: July 9, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)