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.
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.
China1 site, 1 recruiting
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266042
youxin ji, MD, PhD, 8653268665078, niekeke@uor.edu.cn
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.
- Conditions
- Overall Response Rate
- 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 group | Role | What they receive |
|---|---|---|
| bevacizumab plus cisplatin arm | Experimental | Not described Receives: Drug: Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2 |
| cisplatin arm | Active comparator | cisplatin 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.
overall response
Measured: 4 weeks
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.
- First posted29 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall Response RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youxin Ji, Qingdao Central Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions-A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07090525
- Acronym / sponsor ID
- KY202508203
- Conditions
- Overall Response Rate
- Keywords
- Bevacizumab, malignant serous effusions, Randomized study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a prospective, three-center, randomized, phase II clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab plus cisplatin arm | Experimental | Drug: Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2 |
| cisplatin arm | Active comparator | Drug: cisplatin 40mg/m2 intracavity injectioncisplatin 40mg/m2 intracavity injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2, repeat use on 21st day if the serous effusion not controlled | Drug | bevacizumab plus cisplatin arm |
| cisplatin 40mg/m2 intracavity injectioncisplatin 40mg/m2 intracavity injection | Drug | cisplatin arm |
Primary outcome
overall response
Time frame: 4 weeks
overall response
Time frame: serous effusion ORR at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.