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Trial Title:
Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer
NCT ID:
NCT05965141
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Bevacizumab
Carboplatin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Aribulin;carboplatin;bevacizumab
Description:
Aribulin combined with carboplatin and bevacizumab in first-line treatment of
platinum-sensitive recurrent ovarian cancer.
Arm group label:
Aribulin in combination with carboplatin and bevacizumab
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965141
