Skip to content

A Phase II trial of Acteinib combined with Bevacizumab in the treatment of brain metastases from advanced EGFR mutation-positive lung adenocarcinoma

A Phase II trial of Acteinib combined with Bevacizumab in the treatment of brain metastases from advanced EGFR mutation-positive lung adenocarcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033102
Enrollment
Unknown
Registered
2020-05-20
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Lung Cancer

Interventions

experimental group:Acteinib and Bevacizumab

Sponsors

Maoming People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male or female patients, 18-75 years old; 2.PS02 3. Patients with lung adenocarcinoma confirmed by histology or cytology and detected EGFR mutation; 4. Patients with life expectancy greater than 12 weeks; 5. Patients willing to sign informed consent; 6. Patients with evaluable lesions in the brain should have more than 3 lesions, and the largest lesions should be more than 1cm; 7. Patients who can follow the research and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Patients with any unstable systemic diseases (including active infection, poor control of hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic diseases); 2. Patients who have received EGFR inhibitors (including small molecule or monoclonal antibody treatment) and systematic anti-tumor treatment before treatment; 3. Patients who received radiotherapy for brain metastases; 4. Any patients with obvious ocular abnormalities, especially severe dry eye syndrome, dry keratoconjunctivitis, severe exposure keratitis or other diseases that may increase epithelial damage; 5. Patients who are unable to receive oral administration, need intravenous high energy nutrition, have previously had surgery affecting absorption or have active peptic ulcer; 6. Lactating women; 7. Granulocyte count is less than 1.5 * 10^9 / L, platelet count is less than 75 * 10^9 / L; 8. Serum bilirubin was 1.5 times higher than the upper limit of normal; 9. AST and ALT were more than 2 times of the upper limit of normal value, and 5 times of the upper limit of normal value in case of liver metastasis. Serum creatinine was 1.5 times higher than the upper limit of normal value, or creatinine clearance rate was less than 50ml / min; 10. Patients with history of hemoptysis (daily blood volume more than 5ml); 11. The mass is central and close to the large blood vessels.

Design outcomes

Primary

MeasureTime frame
Tumor size;Control time of intracranial metastatic FOCI;

Secondary

MeasureTime frame
Remission rate of brain metastasis;Total time of disease progression;Six-month and one-year survival rates;Relationship between therapeutic effect and gene EGFR EXON 18-21 mutation;Progression-free intracranial survival time after progression;Non-progressive extracranial survival time;Objective intracranial remission rate;Safety and tolerability;

Countries

China

Contacts

Public ContactYisheng Huang

Department 1 of Oncology, Maoming People's Hospital

hysd0760@163.com+86 13719211288

Outcome results

None listed

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