Ovarian Cancer
Conditions
Keywords
ovarian cancer, platinum resistance, Fluzoparib, Dalpiciclib
Brief summary
This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.
Detailed description
1. Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer. 2. Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions. 3. Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients. 4. Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
Interventions
DRUGFluzoparib
150mg oral bid. A PARP inhibitor that mainly exerts its inhibitory effect on tumor cells by inhibiting DNA repair.
DRUGDalpiciclib
150mg oral qd d1-21, q4w. Inhibitor of Cyclin D-CDK4/6 that can inhibit the cell cycle, thereby inducing cell apoptosis.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years old; 2. Sign the informed consent form; 3. Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer. 4. Tumor recurrence or progression within 6 months after using platinum-based drugs;
Exclusion criteria
1. Any uncontrolled medical condition that may put the patient at high risk during treatment . 2. Receipt of any other investigational medicinal product within the last 30 days before randomization. 3. Patients with ovarian cancer excluded by pathological or clinical diagnosis; 4. Physical intolerance patients; 5. Patients who are unwilling to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Two years | Progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | Two years | Overall Survival |
| ORR | Two years | Overall Remission Rate |
Countries
China
Contacts
Primary ContactXingzhu Ju, MD
Outcome results
None listed