this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities
this is an double blinded controlled preventive study to evaluate the preventive effect of this is an preventive traditional chinese medicine TDX105 plus Urea Ointment compared with placebo plus Urea Ointment on Regorafenib induced Dermatologic Toxicities
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
152
Experimental group Traditional chinese medicine TDX105
he control group received placebo granules mixed with dextrin and food coloring
Cancer hospital Chinese academy of Medical sciences
Beijing, Beijing Municipality, China
incidence of grade 3 hand-foot skin reaction
Evaluation criteria for common adverse events (CTCAE) 5.0
Time frame: Once a week from the beginning to 2 months
Grade 1-2 hand and foot skin reaction rate
Evaluation criteria for common adverse events (CTCAE) 5.0
Time frame: Once a week from the beginning to 2 months
Withdrawal rate of regorafenib within 2 cycles
Weekly telephone follow-up
Time frame: Once a week from the beginning to 2 months
progression-free survival
Response Evaluation Criteria In Solid Tumors 1.1
Time frame: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
tumor control rate
Response Evaluation Criteria In Solid Tumors 1.1
Time frame: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
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