Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions

ConditionOverall Response Rate

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorQingdao Central Hospital

About this trial

The purpose of this study is to explore the efficacy and safety ofof bevacizumab plus cisplatin compare with cisplatin in the treatment of malignant serous effusion in patients with advanced adenocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign informed consent;

Treatment naive serous effusion of patients with adenocarcinoma without activating gene mutation.

Eastern Cooperative Oncology Group (ECOG) score ≤ 2;

Survival is expected to exceed 3 months

Disqualifiers

The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks; The subject had participated any clinical trials in the past 4 weeks; The subject had previously received bevacizumab of pleural perfusion therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2
Drug
Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2, repeat use on 21st day if the serous effusion not controlled
cisplatin 40mg/m2 intracavity injection
Drug
cisplatin 40mg/m2 intracavity injection

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: bevacizumab plus cisplatin armExperimental treatment 1 intervention

Group B: cisplatin armActive comparator 1 intervention

Trial outcomes

Primary outcomes

overall response

Time frame

4 weeks

overall response

Time frame

serous effusion ORR at 4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qingdao Central Hospital

Lead sponsor

Source ClinicalTrials.gov

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