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NOT YET RECRUITING
NCT07047066
PHASE2

A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

A Phase II clinical study is planned to evaluate the efficacy and safety of fluzoparib combined with temozolomide in newly diagnosed glioblastoma patients after completing standard concurrent chemoradiotherapy (CCRT), explore the effectiveness and safety of this regimen, and find a better treatment option for glioblastoma patients

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-07-10

Completion Date

2027-07-31

Last Updated

2025-07-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fluzoparib with Temozolomide

Fluzoparib: 100mg, po.bid. Q4W, d1-28, for a total of 6 cycles Temozolomide (TMZ): 150-200 mg/m2, po. Q4W, d1-5, for a total of 6 cycles If unacceptable toxicity occurs and a dose reduction is required, it is recommended to first reduce the dose from 100 mg (2 tablets) to 50 mg (1 tablet) twice a day. If further dose reduction is required, it is recommended to reduce the dose from 50 mg (1 tablet) twice a day to 50 mg (1 tablet) once a day. If it is still intolerable, the patient should withdraw from the clinical study. The TMZ dose is adjusted by the investigator according to standard chemotherapy requirements. Adjuvant TMZ treatment of less than 6 cycles is allowed depending on the subject's condition (e.g. confirmed disease progression, intolerable toxicity, etc.). Tumor assessment is performed during two cycles of TMZ (q8w±7 days) during the study or when clinically indicated