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A multicenter clinical trial study of the PARP inhibitor niraparib combined with radiation therapy in the treatment of children with H3K27M mutation diffuse intrinsic pontine glioma (DIPG)

A Study of niraparib with radiation therapy in the treatment of children with histone H3K27M mutation diffuse intrinsic pontine glioma (DIPG)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068357
Enrollment
Unknown
Registered
2023-02-16
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric diffuse intrinsic pontine gliomas

Interventions

Control Group 1:None Treatment
Control Group 2:Radiation therapy (60Gy)
Test Group:Radiation therapy (60Gy) + Niraparib (100 mg/d)

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 16 Years

Inclusion criteria

Inclusion criteria: a.Patients with newly diagnosed H3K27M mutant DIPG, age must be = 3 years of age and = 16 years of age at the time of study entry for patients diagnosed with DIPGall sexes eligible. b.DIPG patients must have been biopsied and accepted standard radiation therapy. c.DIPG patients haven't received any chemotherapy, immunotherapy and other treatment. d.Lansky score = 50, normal organ function, normal Blood routine test and so on. e.Voluntary and sign a consent form.

Exclusion criteria

Exclusion criteria: a.No H3K27M mutant DIPG, recurrent DIPG. b.Patients with uncontrollable infectious disease. c.Have other malignant tumor history. d.Unable to tolerate radiotherapy. e.Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Design outcomes

Primary

MeasureTime frame
overall survival;Side Effect;Volume of the Tumor;KPS;

Secondary

MeasureTime frame
progress free of survival;

Countries

China

Contacts

Public ContactXinjun Wang

The Third Affiliated Hospital of Zhengzhou University

wangxj@zzu.edu.cn+86 13700883378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026