Spinal fluid chemo cocktail targets tough brain cancer spread
NCT ID NCT06663306
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether injecting two cancer drugs (pemetrexed and bevacizumab) directly into the spinal fluid is safe for people with a specific type of lung cancer that has spread to the lining of the brain. The trial will enroll 19 adults whose cancer has worsened despite standard treatment. The main goal is to check for side effects, but researchers will also track how long participants live.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pemetrexed and bevacizumab
- What this could lead to
- If it works, this could point toward a new treatment option for lung cancer that has spread to the lining of the brain, a condition with very few options.
- What could go wrong
- This is a very early phase 1 trial with only 19 people, so it is primarily testing safety, not effectiveness. The drugs are given directly into the spinal fluid, which carries risks like infection or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 19 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years; * ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases. * Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM); * Unsatisfactory efficacy of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment; * Expected survival time ≥ 1 month; * The laboratory test results meet the following criteria:Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN ; Creatinine≤ 2.0 × ULN,or Creatinine clearance rate (CrCl) ≥ 50 mL/min; * Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study; * Understand and sign the informed consent form. Exclusion Criteria: * Positive for human immunodeficiency virus (HIV) ; * History of allergy to pemetrexed or bevacizumab; * History of pemetrexed and/or bevacizumab intrathecal Injection; * Presence of contraindication of bevacizumab: 1. Uncontrolled hypertension(systolic pressure≥150mmHg,or diastolic pressure≥100mmHg;History of hypertensive crisis or hypertensive encephalopathy; 2. Urine protein≥2+,or 24-hour urine protein≥2g; 3. Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia; 4. Major hemoptysis within the past 1 month; History of coagulation disorders; 5. Presence of serious non-healing wounds, ulcers, or bone fractures 6. Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction; 7. Presence of macrovascular invasion; 8. Some neurological disorders unrelated to tumors,such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis; * Brain/spinal cord radiation therapy within 1 week before enrollment; * Pregnant and lactating female; * Refuse to use contraception during the study period; * Individuals considered by the investigator to be unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Chest Hospital
RECRUITINGShanghai, 200030, China
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