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Overall Response RatePhase 2NCT07090525

Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions

A Phase 2 study testing Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2 and cisplatin 40mg/m2 intracavity injection in people with Overall Response Rate, run by Qingdao Central Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Overall Response Rate
What is being tested?
Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2 and cisplatin 40mg/m2 intracavity injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Jul 2025to 1 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
  • Laboratory results:
  • White blood cell count <3 × 109 / L, neutrophil count <1.5 × 109 / L, platelet <75 × 109 / L, or hemoglobin <8g / dL; Coagulation abnormalities (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time (APTT) > 1.5 ULN), with bleeding tendency or being treated with thrombolysis or anticoagulation; Serum total bilirubin ≥1.5 ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 ULN in the absence of liver metastases; ALT or AST ≥5 ULN in liver metastases; Serum albumin <30g / L; Serum creatinine ≥ 1.5 ULN or creatinine clearance <40ml / min; Urine routine urinary protein ≥ ++, or 24 hours urine protein ≥ 1.0 g; Hypertension cannot be controlled by drugs; Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure; Imaging (CT or MRI) showed a tumor lesion 5 mm away from the large vessels, or the presence of invasive central vasculature of the central tumor; imaging (CT or MRI) showed significant cavitation or necrosis of the lung tumor; Other diseases that may cause haemoptysis; Imaging (CT or chest radiograph) showed significant pneumothorax, fluid pneumothorax; Bilateral pleural cavity to a large number of effusion or encapsulated pleural effusion; Obvious cough blood in 6 months, or daily hemoptysis amounted to half a teaspoon (2.5ml) or more; Significant bleeding symptoms or with definite bleeding tendency within 12 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, occult blood ++ and above, intracerebral hemorrhage, vasculitis, or with congenital or acquired coagulopathy disorders; Thrombosis, cancer thrombosis (including arteriovenous thrombosis, tumor thrombus, pulmonary embolism, transient ischemic attack, etc.) occurred within 12 months; There are gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases or other diseases may cause gastrointestinal bleeding or perforation; Severe respiratory diseases, or need long-term oxygen, corticosteroid treatment of diseases such as chronic obstructive pulmonary disease, interstitial lung disease and respiratory failure; The toxicity of previous antineoplastic therapies has not yet recovered to below grade 2 or has not fully recovered; Patients with uncontrolled central nervous system metastasis; There are serious uncontrolled systemic diseases, such as nephrotic syndrome, infection, poorly controlled diabetes; Patients with active HIV(human immunodeficiency virus), HBV(hepatitis B virus), or HCV(hepatitis C virus) infection; Patients had undergone surgery (<28 days) or did not heal completely, or had other unhealed wounds before the study; Patients known to be allergic to bevacizumab or any of the components of the drug; Pregnant or lactating female patients, or unwilling to take contraceptive measures of reproductive age patients (including men); There is a serious psychological or mental abnormality, or lack of compliance; The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of findings.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

youxin ji director of oncology, md, phD contact

86-53268665078

niekeke@uor.edu.cn

China1 site, 1 recruiting
  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

    youxin ji, MD, PhD, 8653268665078, niekeke@uor.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions-A Prospective Randomized Controlled Study

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

Read the detailed description

This study is a prospective, three-center, randomized, phase II clinical study.

Being tested
Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2, cisplatin 40mg/m2 intracavity injection
Keywords
Bevacizumab, malignant serous effusions, Randomized study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2Drug

    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 injectionDrug

    cisplatin 40mg/m2 intracavity injection

Study groups in NCT07090525
Study groupRoleWhat they receive
bevacizumab plus cisplatin armExperimentalNot described
Receives: Drug: Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2
cisplatin armActive comparatorcisplatin 40mg/m2 intracavity injection
Receives: Drug: cisplatin 40mg/m2 intracavity injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response

    Measured: 4 weeks

  2. overall response

    Measured: serous effusion ORR at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07090525
Sponsor's protocol ID
KY202508203
Status last verified
Jul 2025
First submitted
16 Jul 2025
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2 and cisplatin 40mg/m2 intracavity injection in people with Overall Response Rate, run by Qingdao Central Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact youxin ji director of oncology, md, phD (86-53268665078, niekeke@uor.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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