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A prospective randomized controlled study of apatinib combined with stereotactic radiotherapy for brain metastases with moderate to severe peritumoral edema

A prospective randomized controlled study of apatinib combined with stereotactic radiotherapy for brain metastases with moderate to severe peritumoral edema

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032043
Enrollment
Unknown
Registered
2020-04-18
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain metastases

Interventions

experimental group:Apatinib combined with stereotactic radiotherapy

Sponsors

Department of Oncology, the Second People's Hospital of Yibin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Malignant tumors diagnosed by pathology, there are brain metastases ( 3, severe edema; 3. Karnofsky performance status (KPS score) >= 60 points; expected survival time> 3 months. 4. Routine laboratory testing of bilirubin = 80% of the normal value range . Absolute white blood cell count (WBC) >= 3.5 x 10^9 / L, absolute neutrophil count (ANC) >= 1.5 x 10^9 / L, hemoglobin >= 90g / L, platelet (PLT) >= 75 x 10^9 / L. 5. If there is a history of seizures, antiepileptic therapy should be performed and stabilized for 1 week. 6. Surgery is unnecessary or high-risk, and patients are unwilling to undergo surgical treatment. 7. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with brain metastases from small cell lung cancer; 2. A single patient with brain metastases greater than 4 cm in diameter; 3. Those who have been confirmed to be allergic to apatinib and / or its accessories; 4. Pregnant or lactating women; 5. Significant clinically significant bleeding symptoms or clear bleeding tendency, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above at baseline, or suffering from vasculitis, etc. within 3 months before enrollment; 6. Abnormal blood coagulation function (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds or APTT> 1.5 ULN), have bleeding tendency or are undergoing thrombolysis or anticoagulation treatment; use anticoagulant or vitamin K antagonist Patients treated with agents such as warfarin, heparin or similar drugs; Note: Under the premise that the international normalized ratio of prothrombin time (INR) = 140 mmHg or diastolic blood pressure >= 90 mmHg, despite the best medical treatment); 11. Patients with central metastases or cavities of lung squamous cell carcinoma with peritumoral edema that include or invade major blood vessels 12. Urinary routines suggest that urine protein >= ++ and confirmed 24-hour urine protein quantification> 1.0 g; 13. The investigator considers it unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Changes of edema volume and edema index around the tumor;

Secondary

MeasureTime frame
kamofsky performance status;Average daily dose of dexamethasone and mannitol;Objective response rate;Disease control rate;Total survival;

Countries

China

Contacts

Public ContactWang shanbing

Department of Oncology, the Second People's Hospital of Yibin

275915691@qq.com+86 13659037910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026