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The randomized controlled study of intrathoracic application of recombinant human endostatin single or combined with cisplatin for the treatment of malignant pleural effusion

The randomized controlled study of intrathoracic application of recombinant human endostatin single or combined with cisplatin for the treatment of malignant pleural effusion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008803
Enrollment
Unknown
Registered
2016-07-08
Start date
2016-08-01
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

lung cancer

Interventions

endostar monotherapy group:endostar monotherapy
endostar combined cisplatin group:endostar combined cisplatin
Cisplatin monotherapy group:Cisplatin monotherapy

Sponsors

Chongqing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Malignant pleural effusion was confirmed by pathological examination; 2. Merger of medium dose or amount of the above pleural effusion, (ultrasound shows hydrothorax maximum diameter 4 cm or higher)First treatment or conventional chemotherapy drugs and/or biological response regulator is invalid;(note: ultrasound tip 4 cm or less for a small amount of effusion, 4-6 cm for the amount of effusion, 6 cm for a large number of effusion or higher) 3. Aged 18 to 80 years; 4. KPS > 60 points; 5. Expected to survive more than 3 months; 6. The main organ within 7 days before the treatment, meet the following criteria: 1) Blood routine standard (No blood transfusion within 14 days); Hemoglobin (HB) was 90 g/L or higher; Neutrophils absolute value (ANC) acuity 1.5 x 10^9/L; The platelet (PLT) = 80 x 10^9/L; 2) Biochemical inspection standard: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or less 2 times the upper limit of normal (ULN), such as with liver metastasis, ALT and AST 5 x ULN or less; Total bilirubin (TBIL) was 1.5 x ULN or less; Serum creatinine (Cr)was 1.5 x ULN or less or creatinine clearance (CCr) or 60 ml/min; 7. Patients volunteered for the study, signed informed consent; 8. more than 4 weeks from major surgery 9. more than 4 weeks from the end of the radiation and chemotherapy.

Exclusion criteria

Exclusion criteria: 1. Used other studied drugs within 30 days, or in other clinical research at the same time; 2. Less than six months after myocardial infarction, or have unstable angina and cardiac insufficiency at present; 3. With severe chronic obstructive pulmonary disease (copd) and/or respiratory failure, severe intestinal adhesion; 4. Patients with poor compliance, or suffering from mental illness; 5. known allergic to this experimental drug and its accessories; 6. Activity or failed to control the serious infection; 7. Pregnant patients or patients with nursing, don't want to take contraceptive measures of reproductive age patients (including men); 8. Not the malignant pleural effusion.

Design outcomes

Secondary

MeasureTime frame
Quality of life;Adverse reactions;

Primary

MeasureTime frame
Objective response rate;

Countries

China

Contacts

Public ContactHuiqing Yu

Chongqing Cancer Hospital

yhqyhqdyx@aliyun.com+86 15909391166

Outcome results

None listed

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