Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluzoparib, Dalpiciclib.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer: a Phase II Clinical Study
Overview
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
- Drug Fluzoparib
150mg oral bid. A PARP inhibitor that mainly exerts its inhibitory effect on tumor cells by inhibiting DNA repair. - Drug Dalpiciclib
150mg oral qd d1-21, q4w. Inhibitor of Cyclin D-CDK4/6 that can inhibit the cell cycle, thereby inducing cell apoptosis.
Primary outcome measures
- PFS [Time frame: Two years]
Secondary outcome measures (2)
- OS [Time frame: Two years]
- ORR [Time frame: Two years]
Eligibility criteria
Inclusion criteria
- Age≥18 years old;
- Sign the informed consent form;
- Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer.
- Tumor recurrence or progression within 6 months after using platinum-based drugs;
Exclusion criteria
- Any uncontrolled medical condition that may put the patient at high risk during treatment .
- Receipt of any other investigational medicinal product within the last 30 days before randomization.
- Patients with ovarian cancer excluded by pathological or clinical diagnosis;
- Physical intolerance patients;
- Patients who are unwilling to participate in the clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan university shanghai cancer center, Deparment of gynecologic oncology — Shanghai
Identifiers
NCT: NCT06552858 · FD-OCR-2024