Can a 72-Hour infusion protect the brain after radiosurgery?
NCT ID NCT07841106
First seen Sep 25, 2026 · Last updated Oct 02, 2026 · Updated 2 times
Summary
Researchers are testing recombinant human endostatin (Endostar) in people with non-small cell lung cancer that has spread to the brain and who are scheduled for stereotactic radiosurgery. The trial compares giving Endostar early, within two weeks after radiosurgery, with giving it later as a rescue treatment. The main goal is to see whether the drug reduces peritumoral brain edema, the swelling around tumors, and whether it is safe. Participants receive four cycles of a 72-hour continuous intravenous infusion, one cycle every three weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human endostatin (Endostar), given as a 72-hour intravenous infusion
- What this could lead to
- If it works, this could offer a way to prevent or ease the brain swelling that radiosurgery can cause in people with lung cancer that has spread to the brain.
- What could go wrong
- This is a small Phase 2 trial with 49 participants, so any benefit seen may not hold up in larger studies. Endostar is given by a 72-hour continuous infusion, which may be inconvenient, and it can carry risks such as bleeding or blood pressure changes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 49 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
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 to 75 years
- 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 1. Karnofsky performance status (KPS) score ≥60. 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 3. Baseline contrast-enhanced brain MRI confirms 1-15 brain metastases, with a total volume of all lesions \<15 mL, and the largest lesion with a maximum diameter ≤4.0 cm or volume ≤10 mL. 4. Cohort A: Planned to receive SRS, and baseline MRI shows significant peritumoral edema (edema index \>2), where EI = (tumor volume + edema volume) / tumor volume. Cohort B: Radiographic (MRI) evidence of radiation-induced brain edema/necrosis after SRS (usually ≥3 months after SRS). 5. Prior or concurrent radiotherapy for extracranial lesions is allowed. Prior TKI, chemotherapy, or immunotherapy is allowed. After enrollment, systemic therapy may be continued or adjusted according to clinical need. 6. Within 14 days before study treatment, bone marrow and major organ function must meet the following criteria: ANC ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L; total bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; serum creatinine ≤1.5×ULN or CrCl ≥45 mL/min; INR ≤1.5; APTT ≤1.5×ULN; urine protein \<2+; if urine protein ≥2+, 24-hour urine protein \<2 g. 7. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment. All patients of reproductive potential must agree to use highly effective contraception during the study and for 6 months after the last dose. 8. Patients voluntarily participate, have signed the written informed consent form (ICF), and are expected to comply with and follow all study requirements. Exclusion Criteria 1. Known allergy to Endostar or any of its excipients. 2. Received any other anti-angiogenic therapy within 4 weeks before the first dose. 3. Uncontrolled hypertension despite medication (SBP \>150 mmHg and/or DBP \>100 mmHg). 4. History of major bleeding (e.g., hemoptysis, gastrointestinal bleeding) or current active bleeding, bleeding tendency, or coagulation disorder. 5. History of arterial thromboembolic events (e.g., MI, unstable angina, CVA, or TIA) within 6 months before the first dose. 6. Symptomatic CHF (NYHA Class ≥ II) or severe arrhythmia requiring treatment. 7. Severe hepatic/renal insufficiency: total bilirubin \>1.5×ULN; or ALT/AST \>2.5×ULN; or serum creatinine \>1.5×ULN and CrCl \<45 mL/min. 8. Urine protein ≥++, or 24-hour urine protein ≥2.0 g. 9. History of gastrointestinal perforation, active gastrointestinal bleeding, intra-abdominal abscess, or active IBD. 10. Symptomatic uncontrolled brain metastasis hemorrhage or obvious intracranial hypertension crisis, as judged by the investigator. 11. Contraindications to MRI. 12. Pregnant or lactating women. 13. Any severe acute/chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase risk, interfere with results, or affect the investigator's judgment of the patient's ability to complete the study. 14. Poor compliance, and the patient is not expected to complete all necessary treatment and follow-up assessments.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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