This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis.
1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histopathology is confirmed small cell lung cancer .
4.Leptomeningeal metastasis (LM) is defined by the presence of typical clinical symptoms, positive cerebrospinal fluid (CSF) cytology, detection of cell-free DNA (cfDNA) in CSF by next-generation sequencing (NGS), or imaging findings consistent with typical meningeal metastases.
1. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.
Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
3. Presence of spinal cord compression or meningeal metastasis.
4. History of other malignant tumors within 2 years.
Single group
Intrathecal Pemetrexed
DrugIntrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly until progressive disease.
Overall Survival
OS was defined as the duration from the start of intrathecal pemetrexed to patient death
Intracranial progression-free survival (I-PFS)
Intracranial progression-free survival was defined as the duration from the start of intrathecal pemetrexed to the worsening of neurological symptoms, radiological confirmation of brain progression, or patient death
Intracranial Objective Response Rate (I-ORR)
To assess Intracranial overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
clinical remission rate
Clinical Response Rate was defined as the ratio of the patient whose neurological symptoms and KPS improved according to the criteria of clinical response
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
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Hunan Province Tumor Hospital
Lead sponsor
Second People's Hospital of Hunan
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
