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NOT YET RECRUITING
NCT07841106
PHASE2

Early Prophylactic Versus Late Salvage Recombinant Human Endostatin in Managing Radiosurgery-Induced Brain Injury for NSCLC Brain Metastases

Sponsor: Jiangmen Central Hospital

View on ClinicalTrials.gov

Summary

Primary Purpose:To preliminarily evaluate the efficacy and safety of recombinant human endostatin (Endostar) in the early prophylactic cohort (Cohort A) and late salvage cohort (Cohort B) for radiation-induced brain injury after stereotactic radiosurgery (SRS) in patients with non-small cell lung cancer (NSCLC) brain metastases, with a focus on the improvement rate of peritumoral brain edema.Secondary Purpose:To explore the effects of Endostar treatment on neurological function, quality of life, and survival outcomes in patients with NSCLC brain metastases following SRS; and to evaluate the convenience and compliance of the "72-hour continuous intravenous pump infusion" regimen.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2026-09-01

Completion Date

2028-04-30

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

Recombinant Human Endostatin (Endostar)

Dosage Regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days). Treatment Cycle: Every 3 weeks (21 days) constitutes one cycle, for a total of 4 cycles. Route of Administration: Intravenous infusion (continuous pump infusion). Treatment Timing: Cohort A (early prevention cohort): The first cycle should be initiated within 14 days after stereotactic radiosurgery (SRS). Total Treatment Duration: Approximately 12 weeks (4 cycles, 21 days per cycle).

DRUG

Recombinant Human Endostatin (Endostar)

Dosage regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days). Treatment cycle: One cycle every 3 weeks (21 days), for a total of 4 cycles. Route of administration: Intravenous infusion (continuous pump infusion). Timing of treatment: Cohort B (late salvage cohort): initiate the first cycle of treatment within 14 days after confirmed diagnosis of radiation-induced brain edema/necrosis (usually ≥3 months after SRS). Total duration of treatment: Approximately 12 weeks (4 cycles, 21 days per cycle).