This is a prospective phase II, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer.
This is a phase II prospective, single-center, single-arm clinical study for platinum-sensitive recurrent ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer. Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24 months. 1. Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab. 2. Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every 21 days; Carboplatin: AUC=5\~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90 min,d1, every 21 days. The dose can be adjusted according to the state of the patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.
Objective response rate
The proportion of subjects who achieved PR and CR.
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Disease control rate
Percentage of subjects who achieved PR, CR, and SD.
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Progression-free survival time
The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
Clinical benefit rate
Percentage of subjects who achieved PR, CR, and SD for at least 24 weeks.
Time frame: During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.
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