Ovarian Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGAribulin;carboplatin;bevacizumab
Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with measurable or immeasurable disease (RECIST v1.1) or CA 125 evaluable disease (GCIG criteria) or histologically confirmed diagnosis of recurrent ovarian cancer. * First disease recurrence after first-line platinum chemotherapy \>6 months. * 18 years of age ≤75 years of female. * Expected survival ≥ 3 months.
Exclusion criteria
* Partial tumor related symptoms. * Partial comorbidity. * Subjects developed new secondary malignancies. * other.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 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. | The proportion of subjects who achieved PR and CR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 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. | Percentage of subjects who achieved PR, CR, and SD. |
| Progression-free survival time | 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. | The time between the patient's first treatment date and any recorded tumor progression or death from any cause. |
| Clinical benefit rate | 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. | Percentage of subjects who achieved PR, CR, and SD for at least 24 weeks. |
Contacts
Primary ContactJingqi Chen, MD
Outcome results
None listed