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Open prospective randomized clinical trials of 5% ethanol-cisplatin in the treatment of non-small cell lung cancer malignant pleural effusion

5% ethanol-cisplatin in the treatment of non-small cell lung cancer malignant pleural effusion

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006341
Enrollment
Unknown
Registered
2015-05-02
Start date
2015-06-01
Completion date
Unknown
Last updated
2017-04-18

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

1:Therapy with intravenous chemotherapy combined with pleural effusion drainage
2:Intravenous chemotherapy combined with CIS-Platinum intrapleural therapy
3:Intravenous chemotherapy combined with 5% ethanol and cisplatin injection therapy

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. To be aged 18 to 80 years old; 2. patients were diagnosed of non-small cell lung cancer and malignant pleural effusion by histopathologic examinations (histological or cytological); 3. measurable lesions (RECIST1.1 standard) (CT or MRI); 4. ECOG physical status score: 0-2 points; 5. No EGFR mutation or ALK gene rearrangement in tumor tissues of patients; 6. The patient has been received first-line chemotherapy; 7. Main organ functions are well: artery SpO2 >= 90%; white blood cell count >= 3*10^9/L (and = 1.5*10^9/L, platelet count >100*10^9/L; the ALT and AST are = 60ml/ Min; 8. The patient's consent to participate in trials; 9. The expected survival less than 2 months.

Exclusion criteria

Exclusion criteria: 1. Non-small cell lung cancer complicated with cardiac dysfunction or hepatic insufficiency or renal insufficiency. 2. Patients who received local treatments of chest within 1 month ; 3. PT or APTT is more than two times of the normal range of high value, platelet counts of less than 50*10^9/L.

Design outcomes

Primary

MeasureTime frame
OS;PFS;

Secondary

MeasureTime frame
CR+PR;QOL;Tumor Markers;

Countries

China

Contacts

Public ContactNiu Qi
niu.qi@btch.edu.cn+86 18501151767

Outcome results

None listed

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