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

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 an

Trial Details

NCT ID
NCT06376292
Phase
PHASE2
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Intrathecal Injection of Thiotepa+Radiation+Systemic Treatment of Primary Diseases
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • 1\) Voluntary participation in clinical research: fully understand and be informed of this study, and sign an informed consent form in writing; Wil…
  • 2\) Age: ≥ 18 years old, both male and female. 3) Solid tumor patients diagnosed with meningeal metastasis according to the EANO-ESMO guidelines 4)…
  • Blood routine: Absolute neutrophil count (ANC) ≥ 1.5'109/L (1500/mm3), platelet count ≥ 75'109/L, hemoglobin count ≥ 9 g/dL (if bone marrow is invo…
  • Liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ …

For full eligibility, visit ClinicalTrials.gov.

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