Non-small Cell Lung CancerPhase 2NCT02054052
Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer
A Phase 2 study testing Bevacizumab in people with Non-small Cell Lung Cancer and Malignant Pleural Effusion, run by Haihong Yang, MD, Pricipal investigator at 1 site in China.
Trial summary
Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Malignant Pleural Effusion
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of non-small cell lung cancer.
- Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
- Symptomatic MPE evaluated by researchers
- Unsuitable for or reject systemic therapy of tumor
- Estimated survival of more than 3 months. 6.18 years or older
Who cannot join
- Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
- Be allergic to bevacizumab
- Pregnant or lactating woman
- Pleural or pericardial infection
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affliliated Hospital of Guangzhou MC
Guangzhou, Guangdong, 510120
About this study
Official title: Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer
Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in treating MPE.
Read the detailed description
Inclusion Criteria:
- Histological or cytological diagnosis of non-small cell lung cancer.
- Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
- Symptomatic MPE evaluated by researchers
- Unsuitable for or reject systemic therapy of tumor
- Continuous TKI treatment after TKI-resistance
- Estimated survival of more than 3 months. 7.18 years or older
Exclusion Criteria:
- Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
- Be allergic to bevacizumab
- Pregnant or lactating woman
- Pleural or pericardial infection
- Being tested
- Bevacizumab
- Keywords
- non-small cell lung cancer, malignant pleural effusion, bevacizumab, intrapleural injection, pericardial effusion
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pleural Effusion, Malignant, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer symptom
Measured: Evaluated by lung cancer symptom scale 21-30 days after the treatment
Secondary outcomes (4)
response rate
Measured: Evaluate response rate 21-30 days after the treatment
Time to progression
Measured: 1 year after the treatment of MPE.
Overall survival
Measured: 1 year after the treatment of MPE
Number of Participants with Adverse Events
Measured: one months after the treatment of MPE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haihong Yang, MD, Pricipal investigator
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
- Investigators
- Haihong Yang, MD, Principal investigator, the First Affiliated Hospital of Guangzhou MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054052
- Sponsor's protocol ID
- GZTO1401
- Status last verified
- Mar 2019
- First submitted
- 27 Jan 2014
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02054052
- Acronym / sponsor ID
- GZTO1401
- Keywords
- non-small cell lung cancer, malignant pleural effusion, bevacizumab, intrapleural injection, pericardial effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Haihong Yang, MD, Pricipal investigatorUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in treating MPE.
Detailed description
Inclusion Criteria:
- Histological or cytological diagnosis of non-small cell lung cancer.
- Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
- Symptomatic MPE evaluated by researchers
- Unsuitable for or reject systemic therapy of tumor
- Continuous TKI treatment after TKI-resistance
- Estimated survival of more than 3 months. 7.18 years or older
Exclusion Criteria:
- Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
- Be allergic to bevacizumab
- Pregnant or lactating woman
- Pleural or pericardial infection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabBevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological diagnosis of non-small cell lung cancer.
- Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
- Symptomatic MPE evaluated by researchers
- Unsuitable for or reject systemic therapy of tumor
- Estimated survival of more than 3 months. 6.18 years or older
Key exclusion criteria (4 listed)
- Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
- Be allergic to bevacizumab
- Pregnant or lactating woman
- Pleural or pericardial infection
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 |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE | Drug | Bevacizumab |
Primary outcome
Lung cancer symptom
Time frame: Evaluated by lung cancer symptom scale 21-30 days after the treatment
4 secondary outcomes
response rate
Time frame: Evaluate response rate 21-30 days after the treatment
Time to progression
Time frame: 1 year after the treatment of MPE.
Overall survival
Time frame: 1 year after the treatment of MPE
Number of Participants with Adverse Events
Time frame: one months after the treatment of MPE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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. This study is not recruiting at the moment.
Haihong Yang, MD principal investigator
the First Affiliated Hospital of Guangzhou MC
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 Bevacizumab in people with Non-small Cell Lung Cancer and Malignant Pleural Effusion, run by Haihong Yang, MD, Pricipal investigator 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer symptom (time frame: Evaluated by lung cancer symptom scale 21-30 days after the treatment). 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 Mar 2019.