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A multicenter and randomized controlled clinical study on the treatment of malignant pleural effusion with Endostar and/or Nedaplatin

A multicenter and randomized controlled clinical study on the treatment of malignant pleural effusion with Endostar and/or Nedaplatin

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016259
Enrollment
Unknown
Registered
2018-05-22
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-05-28

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

Conditions

malignant pleural effusion

Interventions

Pleural cavity perfusion therapy with Endostar:Endostar
Pleural cavity perfusion therapy with Nedaplatin:Nedaplatin
Pleural cavity perfusion therapy with Endostar and Nedaplatin:Endostar and Nedaplatin

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) It was diagnosed as malignant tumor by histopathologic and cytological examination and was clinically diagnosed as malignant pleural effusion, which was above the moderate; 2) Aged between 18 and 75; 3) ECOG scores 0 ~ 2 points; 4) To be expected to survive for more than 2 months; 5) The main organ function is normal; 6) Voluntary enrollment, signed informed consent, compliance with good compliance with follow-up; 7) More than 4 weeks from major surgery.

Exclusion criteria

Exclusion criteria: 1) the metastasis of the central nervous system which was not controlled by the merger was characterized by cranial high pressure; 2) there is a tendency of bleeding, especially in 4 weeks, with obvious gastrointestinal bleeding, or receiving thrombolysis or anticoagulant therapy; 3) the last systemic chemotherapy was < 4 weeks; 4) use other research drugs within 30 days, or participate in other clinical studies at the same time; 5) severe chronic obstructive pulmonary disease and/or respiratory failure, severe intestinal adhesion; 6) pleural effusion or enveloping pleural effusion; 7) patients with poor compliance, or mental illness, cannot control themselves; 8) it is known that this experimental drug and its auxiliary materials are allergic; 9) there are currently uncontrollable serious infections; 10) patients with gestational or lactating women who are not willing to take contraceptive measures (including men); 11) myocardial infarction occurred within 6 months, or at present unstable angina pectoris and cardiac dysfunction.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Time to progression;Quality of life;Safety;

Countries

China

Contacts

Public ContactKong Jinliang

The First Affiliated Hospital of Guangxi Medical University

kjl071@163.com+86 13978881546

Outcome results

None listed

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