Skip to content

A randomized, controlled, multi-center clinical trial of different endotoxin-dose regimen versus platinum intracavitary in the treatment of advanced non-small cell lung cancer with malignant pleural effusion

A randomized, controlled, multi-center clinical trial of different endotoxin-dose regimen versus platinum intracavitary in the treatment of advanced non-small cell lung cancer with malignant pleural effusion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018690
Enrollment
Unknown
Registered
2018-10-04
Start date
2018-02-01
Completion date
Unknown
Last updated
2018-10-10

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

Conditions

Advanced non-small cell lung cancer with malignant pleural e

Interventions

A:High-dose endovascular perfusion
B:Conventional dose of endovascular perfusion
C:platinum intracavitary

Sponsors

First Affilicated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The histological and / or cytological diagnosis of advanced non-squamous, non-small cell lung cancer; 2. According to the latest stage of IASLC 2009 lung cancer TNM, it is determined as advanced non-small cell lung cancer; 3. Combined with moderate to upper malignant pleural effusion, and ECOG PS: 0-2 minutes; 4. The expected survival =3 months; blood tests: ANC =2×10^9/L and PLT =100×10^9/L and HB=9g/dL; 5. biochemical tests must meet the following criteria: BIL <1.25 times the upper limit of normal (ULN); ALT and AST <2.5 × ULN; if liver metastases, the ALT and AST <5 × ULN; Serum Cr=1 × ULN, creatinine clearance rate =50ml/min (Cockcroft-Gault formula); 6. The electrocardiogram is basically normal, and there is no unhealed wound on the body; 7. Patients who have undergone surgery have been more than 4 weeks since the start of the study and the patient has recovered; 8. Previously no serious allergic reactions to biological agents, especially E. coli genetic engineering products; 9. The patient voluntarily informed consent (ICF).

Exclusion criteria

Exclusion criteria: 1. Benign disease with pleural effusion; 2. A pregnant or lactating women, or female patients who have fertility but have not used contraception; 3. There are serious acute infections that are not controlled,or a suppurative and chronic infection with a prolonged wound; 4. People with serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension; 5. The patient has an uncontrollable neurological, psychiatric or psychiatric disorder with poor compliance and cannot be treated with treatment;The transfer of the central nervous system with symptoms; 6. Having bleeding tendencies.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
TTP;QOL;ECOG;The rate of advers reactions;

Countries

China

Contacts

Public ContactJia Yingjie

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

358558031@qq.com+86 022 27986556

Outcome results

None listed

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