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Clinical trial of different administration of endostar in the treatment of advanced non-small cell lung cancer with malignant pleural effusion

Clinical trial of different administration of endostar in the treatment of advanced non-small cell lung cancer with malignant pleural effusion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033802
Enrollment
Unknown
Registered
2020-06-13
Start date
2020-06-20
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Non small cell lung cancer

Interventions

control group:Intravenous drip endostar
Test group : perfusion endostar into pleural

Sponsors

Xinjiang Medical University Affiliated Oncology Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with advanced non-small cell lung cancer confirmed by cytology or histology; 2. According to the new TNM stage of iaslc2009 lung cancer, patients with advanced non-small cell lung cancer were determined; 3. For patients with malignant pleural effusion with more than medium amount, medium amount is defined as: the pleural effusion >= 3cm in supine position by B-ultrasound, or the amount of pleural effusion in chest X-ray is more than that in the fourth rib of anterior rib. ECoG PS 0-2 points; 4. Patients with expected survival time >= 3 months; blood routine examination criteria should be: absolute neutrophil count (ANC) >= 2 * 10^9 / L, platelet count >= 100 * 10^9 / L and hemoglobin >= 9 g / dl; 5. Biochemical examination shall meet the following standards: (1) Total bilirubin 60 ml / min (Cockcroft Gault formula). 6. The ECG is basically normal, the blood pressure is well controlled, and there is no unhealed wound on the body; 7. For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of the study and the patients have recovered; 8. Those who have no serious allergic reaction to biological agents, especially to genetic engineering products of Escherichia coli; 9. The person signing the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with benign diseases and pleural effusion: the pleural effusion in most lung cancer patients is caused by tumor, but in a few patients, the pleural effusion is negative in many cytological and pathological examinations, and the effusion is neither blood nor exudate. If these factors are considered comprehensively and the clinical results show that the effusion has nothing to do with the tumor, it can be judged as benign pleural effusion; 2. Pregnant / lactating women, or women with fertility but without contraceptive measures; 3. Patients with serious acute infection and not under control, or those with suppurative and chronic infection and the wound is not cured; 4. Patients with previous serious heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and stubborn hypertension; 5. Patients with uncontrollable neurological, mental diseases or mental disorders, poor compliance, unable to cooperate with and describe the treatment response; patients with primary brain tumor or central nerve metastasis, uncontrolled, with obvious intracranial hypertension or neuropsychiatric symptoms; 6. Patients with bleeding tendency.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Quality of life score;safty;

Countries

China

Contacts

Public ContactLiu Chunling

Xinjiang Medical University Affiliated Oncology Hospital

tllzdklcyj@163.com+86 13899931987

Outcome results

None listed

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