Actively Recruiting
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
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-30
58
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate, understand the study, and sign informed consent
- Age 18 to 75 years, male or female
- Diagnosed with leptomeningeal metastasis from a solid tumor per EANO-ESMO guidelines
- Have completed whole brain radiotherapy with 30Gy in 10 fractions
- CNS IPI score 4 or higher
- Increased serum LDH or involvement of more than one extranodal site
- ECOG performance status score of 2 or less
- Expected survival time of at least 3 months
- Adequate organ and bone marrow function without severe dysfunction or immune deficiency
- Left ventricular ejection fraction 50% or higher
- Negative serum pregnancy test and using effective contraception during treatment
- Normal thyroid hormone levels within 10% of range
- Completed ophthalmic examinations including fundus and slit lamp
You will not qualify if you...
- Participating in other clinical studies or less than 4 weeks since last study drug
- History of other malignant tumors within past 5 years
- Received CNS-guided treatment or prevention
- Known HIV infection or AIDS
- Active autoimmune or hematological autoimmune diseases with high recurrence risk
- Active chronic hepatitis B or C infection requiring treatment
- Active pulmonary tuberculosis
- Current interstitial lung disease or infectious pneumonia
- Active infections requiring systemic anti-infective treatment
- Recent severe heart failure, unstable angina, or serious arrhythmias
- QTcF interval over 480 msec unless caused by bundle branch block
- Uncontrollable comorbidities such as severe hypertension or bleeding disorders
- History of mental illness or limited decision-making capacity
- Any condition increasing risk or causing difficulty evaluating toxic reactions
- Other reasons deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang, prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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