Clinical trial · Interventional
Apatinib Combined With Radiotherapy in Patient With BM From Drive Gene Negative NSCLC
A Prospective, Multicenter, Randomized Controlled Trial of Apatinib Combined With Radiotherapy in Patient With Brain Metastases From Drive Gene Negative NSCLC
NCT03801200CI-TRIAL-00056374unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of concurrent radiotherapy with Apatinib in patients with Brain Metastases from drive gene wide-type Non-small-cell Lung Cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apatinib combined with Radiotherapy
- description
- Drugs: Apatinib Apatinib (500 mg/d) was given orally for one week before the brain radiotherapy, and then, continued to be administered at the same way during the brain radiotherapy period (3 weeks). It was given for another one week after the end of the brain radiotherapy. Radiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy/15 to patients with 1-5 metastatic lesions.
- interventionNames
- Drug: Apatinib
- type
- NO_INTERVENTION
- label
- Radiotherapy alone
- description
- Radiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy /15 to patients with 1-5 metastatic lesions.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years old, male or female, signed informed consent; 2. The primary lesion is confirmed by histopathology. The patient with brain metastases confirmed by histopathology or imaging confirmed the brain metastases. All patients with non-small cell lung cancer brain metastases should be recommended for EGFR mutation and ALK gene rearrangement assay,exclusion of patients with NSCLC brain metastases with positive EGFR-sensitive mutations and ALK gene rearrangement detection for TKI treatment; After multidisciplinary consultation and evaluation, patients with single or local multiple metastatic tumors with well-controlled primary lesions, who have the economic ability and are willing to undergo surgery for brain metastatic tumors were excluded. 3. Observable imaging data such as CT, MRI, etc., have measurable lesions as defined by RECIST 1.1 (R09-0262); 4. ECOG PS score: 0-2; 5. Hemogram index: RBC≥3.0×1012/L, WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥100×109/L, Hb≥90g/L 6. the expected survival time ≥ 3 months 7. Renal function: Cr≤1.2×UNL (upper limit of normal value); 8. Liver function: total bilirubin ≤ 1.5 × UNL; ALT, AST ≤ 1.5 × UNL Exclusion Criteria: 1. . Allergies, known to be hypersensitive to any excipients in the study drug. ; 2. . Patients with recurrent brain metastases have previously received brain radiation therapy 3. . Patients with high fever and acute infection; 4. . Patients with active, progressive bleeding or a significant bleeding tendency in the primary lesion; 5. . Participated in any clinical trial of research drugs within 4 weeks prior to enrollment 6. . Diarrhea is the main symptom of the important or newly diagnosed acute gastrointestinal diseases, such as Crohn's disease, malabsorption or any cause of CTC ≥ 2 grade diarrhea. 7. . Current clinically relevant cardiovascular disease or medical history, such as refractory hypertension, NYHA grade 3 congestive heart failure, unstable angina or poorly controlled arrhythmias. Myocardial infarction occurred 6 months before randomization. 8. . Absolute neutrophil count \<1000/mm3; 9. . Platelet count \<50000/mm3; 10. . According to the investigator's point of view, any other serious disease or organ system dysfunction that may affect patient safety or interfere with the safety assessment of the test drug, such as proteinuria (CTCAE4.0-≥3), severe liver and kidney dysfunction (CTCAE4.0-≥3), hand-foot syndrome (CTCAE4.0-≥3) and so on. 11. . There are ulcers, intestinal perforations, and intestinal obstruction. 12. . Pregnant and lactating women 13. . Suspected or indeed have a history of alcohol and drug abuse
References
Publications (1)
- DERIVEDMa J, Pi G, Bi J, Li Y, He H, Li Y, Hu D, Verma V, Han G. Concurrent Apatinib and Brain Radiotherapy in Patients With Brain Metastases From Driver Mutation-negative Non-small-cell Lung Cancer: Study Protocol for an Open-label Randomized Controlled Trial. Clin Lung Cancer. 2021 Mar;22(2):e211-e214. doi: 10.1016/j.cllc.2020.10.007. Epub 2020 Oct 21. PMID 33187916