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Short-Term Efficacy of Local Iodine Pleurodesis Versus Intrapleural Perfusion of Recombinant Human Endostatin Combined with Cisplatin in the Treatment of Non-small Cell Lung Cancer Complicated With Malignant Pleural Effusion: a Randomized Clinical Study

Short-Term Efficacy of Local Iodine Pleurodesis Versus Intrapleural Perfusion of Recombinant Human Endostatin Combined with Cisplatin in the Treatment of Non-small Cell Lung Cancer Complicated With Malignant Pleural Effusion: a Randomized Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045038
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Malignant pleural effusion from non-small cell lung cancer

Interventions

Treatment group:Intrapleural perfusion of endostar combined with cisplatin
Control group:Iodophor was injected into the chest

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Voluntarily participate in the clinical study, fully understand and sign the informed consent, and are willing to be followed and able to complete study procedures; 2.Advanced NSCLC confirmed histologically or pathologically, had not received intrapleural administration within 6 months; 3.Aged >18 years at time of recruitment,; 4.Imaging (chest ultrasound/chest radiography/chest CT) suggested unilateral or bilateral massive pleural effusion; 5.Pleural tissue biopsy or exfoliated pleural fluid cell test confirmed malignant pleural effusion; 6.ECOG-PS score: 0-2; 7.Predicted survival time >12 weeks; 8.No major organ system dysfunction, the liver function, kidney function and heart function were within the normal range, and there was no blood system disease.

Exclusion criteria

Exclusion criteria: 1.Imaging showed the depth of pleural effusion <2cm; 2.Complicated chest infection or infection of other organs; 3.Malignant pleural effusion side had received whole lung, lobectomy after; 4.Lung collapse; 5.Disagree to pleural fixation and/or local intrapleural injection of cisplatin + Endol; 6.Pleural fixation or local intrathoracic perfusion was required; 7.Allergic to the drugs involved in the study; 8.Major organ failure or other serious diseases, such as heart failure, severe arrhythmia, myocardial ischemia, renal dysfunction, proteinuria, refractory hypertension, and combined with blood system disease, recent bleeding history; 9.Poor compliance, or patients with severity mental illness and can't control himself; 10.Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Objective remission rate of pleural effusion;

Secondary

MeasureTime frame
Local pleural effusion has no progression-free survival;Progression-free survival;Quality of life;Duration from intervention to discharge;

Countries

China

Contacts

Public ContactCheng Yuan

Peking University First Hospital

softsnake@bjmu.edu+86 13811659696

Outcome results

None listed

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