Non Small Cell Lung CancerPhase 4NCT02497118
Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
A Phase 4 study testing Endostatin, Vinorelbine and Cisplatin in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Endostatin, Vinorelbine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Jun 2015
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The pathology proved to be non small cell lung cancer (must be histologically).
- At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;
- The patients were evaluated by imaging, laboratory examination and other examination;
- Without chemotherapy or anti angiogenic therapy;
- There can be measured lesions
- Informed consent.
Who cannot join
- Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.
- Severe infection.
- Severe heart disease.Neuropsychiatric disorders, which is not easy to control.
- Severe diabetes.
- There is obvious bleeding tendency.
- The 5 years history of other tumors
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer
This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Endostatin, Vinorelbine, Cisplatin
- Keywords
- lung cancer Anti angiogenesis therapy survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostatinDrug
Also called Endostar
Endostatin,7.5mg/m^2,intravenous, d1-14;
VinorelbineDrug
vinorelbine,25mg/m^2,intravenous, d1, d8;
CisplatinDrug
Cisplatin，75mg/m^2 intravenous,divide into d1-3
| Study group | Role | What they receive |
|---|---|---|
| Endostatin plus NP | Experimental | drug:Endostatins Intravenous drip， 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles Receives: Drug: Endostatin; Drug: Vinorelbine; Drug: Cisplatin |
| NP neoadjuvant chemotherapy | Active comparator | drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles Receives: Drug: Vinorelbine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Regression Rate
Target lesion size reduction ratio
Measured: 3 months
Secondary outcomes (3)
Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Measured: 5 years
Overall Survival
the time from randomization to death.
Measured: 5 years
Clinical Benefit Rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2010
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497118
- Sponsor's protocol ID
- TMUCIH-ENDU-S001
- Status last verified
- May 2014
- First submitted
- 5 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao X, Su Y, You J, Gong L, Zhang Z, Wang M, Zhao Z, Zhang Z, Li X, Wang C. Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects. Oncotarget. 2016 Sep 20;7(38):62619-62626. doi: 10.18632/oncotarget.11547.
PubMed 27566586
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02497118
- Acronym / sponsor ID
- TMUCIH-ENDU-S001
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer Anti angiogenesis therapy survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Jul 2015 (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.
This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endostatin plus NP | Experimental | Drug: Endostatin, Drug: Vinorelbine, Drug: Cisplatindrug:Endostatins Intravenous drip， 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles |
| NP neoadjuvant chemotherapy | Active comparator | Drug: Vinorelbine, Drug: Cisplatindrug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The pathology proved to be non small cell lung cancer (must be histologically).
- At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;
- The patients were evaluated by imaging, laboratory examination and other examination;
- Without chemotherapy or anti angiogenic therapy;
- There can be measured lesions
Key exclusion criteria (6 listed)
- Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.
- Severe infection.
- Severe heart disease.Neuropsychiatric disorders, which is not easy to control.
- Severe diabetes.
- There is obvious bleeding tendency.
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 |
|---|---|---|
| EndostatinAlso: EndostarEndostatin,7.5mg/m^2,intravenous, d1-14; | Drug | Endostatin plus NP |
| Vinorelbinevinorelbine,25mg/m^2,intravenous, d1, d8; | Drug | Endostatin plus NP, NP neoadjuvant chemotherapy |
| CisplatinCisplatin，75mg/m^2 intravenous,divide into d1-3 | Drug | Endostatin plus NP, NP neoadjuvant chemotherapy |
Primary outcome
Tumor Regression Rate
Time frame: 3 months
Target lesion size reduction ratio
3 secondary outcomes
Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Time frame: 5 years
Overall Survival
Time frame: 5 years
Clinical Benefit Rate
Time frame: 3 months
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 14 Jul 2015.
- Derived from this study: PubMed 27566586Zhao X, Su Y, You J, Gong L, Zhang Z, Wang M, Zhao Z, Zhang Z, Li X, Wang C. Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects. Oncotarget. 2016 Sep 20;7(38):62619-62626. doi: 10.18632/oncotarget.11547.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endostatin, Vinorelbine and Cisplatin in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and 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 6 inclusion and 6 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 14 Jul 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Tumor Regression Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02497118, which also lists 1 linked publication.
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 14 Jul 2015.