This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
ICP-192 is a round, uncoated tablet, 5mg, orally.
Objective response rate (ORR)
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: Up to 3 years
Time to response (TTR)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
The adverse event (AE) of ICP-192 assessed by NCI-CTCAE V5.0
Time frame: Up to 3 years
Maximum concentration (Cmax)
Time frame: Up to 3 years
Time to maximum concentration (Tmax)
Time frame: Up to 3 years
Half-life (T1/2)
Time frame: Up to 3 years
Area under the concentration-time curve (AUC)
Time frame: Up to 3 years
Apparent clearance (CL/F)
Time frame: Up to 3 years
Terminal apparent volume of distribution (Vz/F)
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Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGCancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Youan Hosptital,Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Cancer Hospital
Fujian, Fujian, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGMengchao hepatobiliary Hospital of FuJian Medical university
Fuzhou, Fujian, China
NOT_YET_RECRUITINGFoshan First People's Hospital
Foshan, Guangdong, China
NOT_YET_RECRUITING...and 34 more locations
Time frame: Up to 3 years