This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The subjects will receive an oral coating of CHG0521 in the form of drops, in addition to the clinician\'s standard treatment regimen, for a duration of 6 months or until confirmed progression, unacceptable toxicity, or any criteria for withdrawal from the trial.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame: 24 weeks
QOL
Washington Quality of Life Score
Time frame: 24 weeks
PCR
Pathologic Complete Response
Time frame: 24 weeks
DRR
Disease Recurrence Rate
Time frame: 24 weeks
OS
Overall Survival
Time frame: 1 year
AEs
Incidence and severity of adverse events
Time frame: 1 year
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