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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will receive a comprehensive treatment plan consisting mainly of HA-WBRT combined with intrathecal injection of Thiotepa. All eligible patients received intrathecal injection of Thiotepa twice a week for 1 week as induction treatment for 3 weeks, followed by once every week as consolidation therapy for 6 week and then once monthly as maintenance therapy, until progressive disease was observed or intolerance or adverse events (AEs) developed. The injection was administered by qualified individuals (certified personnel in the radiotherapy department of our hospital) . Thiotepa was injected 10mg each time, mixed with cerebrospinal fluid, and then injected slowly for 5-10 minutes. Evaluate the efficacy and safety every 6 cycles according to RANO-LM criteria.

Conditions

• Solid Tumor Leptomeningeal Metastasis

Interventions

Type	Name	Description
DRUG	Intrathecal Injection of Thiotepa+Radiation+Systemic Treatment of Primary Diseases	Participants will receive a comprehensive treatment plan consisting mainly of whole brain 30Gy/10F radiotherapy combined with intrathecal injection of Thiotepa. The injection was administered by qualified individuals (certified personnel in the radiotherapy department of our hospital) twice a week for a total of 4 weeks. Thiotepa was injected 10mg each time, mixed with cerebrospinal fluid, and then injected slowly for 5-10 minutes.

Timeline

• Start date: 2024-01-06
• Primary completion: 2026-01-06
• Completion: 2026-01-06
• First posted: 2024-04-19
• Last updated: 2025-12-30

Locations

1 site across 1 country: China