Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Ovarian Cancer

Treatments: Drug: Aribulin;carboplatin;bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05965141

2022-LCYJ-YY01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Aribulin in combination with carboplatin and bevacizumab

Experimental group

Description:

This is a one-arm study without randomization. There was only one trial group of Aribulin combined with carboplatin and bevacizumab.

Treatment:

Drug: Aribulin;carboplatin;bevacizumab