drugset / Trial / NCT06376292

A Prospective Single Arm Phase II Exploratory Study on the Combination of Whole Brain Radiotherapy, Thiotepa Intrathecal Injection and Systemic Treatment of Primary Diseases in the Treatment of Solid Tumor Leptomeningeal Metastasis

NCT06376292

NaSingle-groupOpen-labelTreatment

Summary

The goal of this prospective, single-arm exploratory clinical study is to explore the safty and efficacy of whole-brain radiotherapy combined with Thiotepa intrathecal injection combined with systemic therapy for the primary disease in the treatment of leptoeningeal metastases in solid tumors How works well was the combined therapy? How safe was combined therapy? Participants will continue systemic treatment, receive HA-WBRT combined with intrathecal injection of Thiotepa. Evaluate the efficacy and safety every 6 cycles. Researchers will evaluate whether this combination treatment is safe and whether it is more effective than previous studies.

Timeline

Start
2024-01-06
Primary completion
2025-09-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Thiotepa Other / unclassified 10 mg Intrathecal

Indications