Abstract 793TiP
Background
Soft tissue sarcomas (STS) are aggressive tumors that are typically managed with surgical resection and radiotherapy. Despite these treatments, advanced or inoperable STS presents significant therapeutic challenges due to radioresistance and adverse side effects. The integration of Poly (ADP-ribose) polymerase (PARP) inhibitors, such as Fluzoparib, effective in treating other cancers, shows promise in overcoming these challenges by inhibiting DNA repair mechanisms activated during radiotherapy.
Trial design
Key inclusion criteria: This single-arm, open-label, phase II clinical trial investigates the combined use of radioactive Iodine-125 seeds implantation and PARP inhibitor (Fluzoparib) in patients with advanced, unresectable STS who have failed previous systemic therapies. Key inclusion criteria include adult patients (≥18 years) with pathologically confirmed STS, measurable lesions per RECIST 1.1, progression post-systemic therapy, ECOG performance status of 0 or 1, and an expected survival of at least 12 weeks. Assuming a targeted ORR of 24%, with a one-sided a of 0.05, a sample size of 25 patients was required to declare the lower limit of 95% CI for ORR to exceed 11% based on the method of Confidence Intervals for One Proportion. With an expected dropout rate of 20%, a total of 32 patients would need to be enrolled. Methods: Patients receive Fluzoparib 150 mg orally twice daily for 60 days starting 48 hours post-radioactive Iodine-125 seeds implantation, with a cumulative treatment duration of up to one year. Tumor response is evaluated monthly during the first cycle, with additional seed implantations administered based on partial remission or stable disease status. Endpoints: The primary endpoint is the objective response rate (ORR) per RECIST 1.1 criteria. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety as assessed by CTCAE.
Clinical trial identification
NCT05894018.
Legal entity responsible for the study
The authors.
Funding
China Anti-Cancer Association - Hengrui PARP Nicotinamide Cancer Research Fund.
Disclosure
All authors have declared no conflicts of interest.