The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment. The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Oral kinase inhibitor
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Union Medical College Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, China
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first).
Time frame: Approximately 10 months since the first subject enrolled.
Objective Response Rate (ORR)
The objective response rate (ORR) is defined as the percentage of participants who achieved confirmed complete response (CR) or partial responses (PR) based on independent radiology review.
Time frame: Approximately 15 months since the first subject enrolled.
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death.
Time frame: Approximately 28 months since the first subject enrolled.
Time to Best Response (TBR)
Time to Best Response(TBR) based on independent radiology review is defined as the duration from the date of the first dose of the investigational drug to the date of confirming the best response.
Time frame: Approximately 15 months since the first subject enrolled.
Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks
Disease control rate (DCR) based on independent radiology review (confirmed CR + confirmed PR + SD for 12 weeks)
Time frame: Approximately 15 months since the first subject enrolled.
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Union Medical College Hospital, Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China