This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.
This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
200mg bid
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Affiliated Cancer Center of Academy of Military Medical Sciences
Beijing, China
Number of Participants with Adverse Events
patients with adverse events/all patients\*100%
Time frame: 54 weeks
Tumor response
complete response and partial response patients/all patients\*100%
Time frame: 54 weeks
Progression-free survival time
median progress-free survival time
Time frame: 54 weeks
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