Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer

Phase 2Not Yet RecruitingNCT06552858

Fudan University30 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

FluzoparibDRUG

150mg oral bid. A PARP inhibitor that mainly exerts its inhibitory effect on tumor cells by inhibiting DNA repair.

DalpiciclibDRUG

150mg oral qd d1-21, q4w. Inhibitor of Cyclin D-CDK4/6 that can inhibit the cell cycle, thereby inducing cell apoptosis.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

PFS

Progression free survival

Time frame: Two years

Secondary Outcomes

Overall Survival

Time frame: Two years

ORR

Overall Remission Rate

Time frame: Two years

Central Contacts

Xingzhu Ju, MD

CONTACT

+86 18601684480 a610278155@163.com

Data from ClinicalTrials.gov

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