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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

NCT07047066 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-07-31
Completion
2027-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07047066 on ClinicalTrials.gov