Clinical trial
A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer
Name
2022-LCYJ-YY01
Description
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.
Trial arms
Trial start
2023-08-01
Estimated PCD
2025-04-01
Trial end
2025-06-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Aribulin;carboplatin;bevacizumab
Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.
Arms:
Aribulin in combination with carboplatin and bevacizumab
Size
38
Primary endpoint
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.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 38, 'type': 'ESTIMATED'}}
Updated at
2023-07-28
1 organization
1 product
1 indication
Indication
Ovarian Cancer