Status:
NOT_YET_RECRUITING
Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metastatic
Lead Sponsor:
Hunan Province Tumor Hospital
Collaborating Sponsors:
Second People's Hospital of Hunan
Conditions:
Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis.
Detailed Description
This is a prospective interventional clinical study to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis. Appro...
Eligibility Criteria
Inclusion
- 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 .
- 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.
- Patients with brain progression after whole-brain radiotherapy.
- 6\. Predicted survival ≥ 12 weeks. .
- 7\. ECOG 0-2.
- 8\. Adequate bone marrow hematopoiesis and organ function.
Exclusion
- 1\. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.
- 2\. Subjects who have received any of the following treatments must be excluded:
- 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.
- 5\. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
- 6\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- 7\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- 8\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
- 9\. Heart-related diseases or abnormalities
- 10\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
- 11\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
- 12\. Live vaccine was given 2 weeks before the first medication.
- 13\. Women who are breastfeeding or pregnant.
- 14\. Hypersensitivity to the test drug and the ingredients.
- 15\. Other conditions assessed by the investigator to be unsuitable for participation in the study.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06497543
Start Date
October 1 2024
End Date
April 30 2026
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yongchang Zhang
Changsha, Hunan, China, 410013