Description:
The purpose of this study is to discuss the efficacy and safety of recombinant human
endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus cisplatin
or carboplatin in the first-line treatment of advanced lung adenocarcinoma with wild-type
EGFR or ALK-negative,compared with chemotherapy without endostar.
Title
- Brief Title: Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma
- Official Title: Recombinant Human Endostatin Durative Transfusion Combined With Pemetrexed Plus Cisplatin or Carboplatin in the First-line Treatment of Advanced Lung Adenocarcinoma With Wild-type EGFR or ALK-negative
Clinical Trial IDs
- ORG STUDY ID:
20160606
- NCT ID:
NCT02804646
Conditions
Interventions
Drug | Synonyms | Arms |
---|
recombinant human endostatin | endostar | endostar and chemotherapy group |
pemetrexed plus cisplatin or carboplatin | pemetrexed disodium | chemotherapy group |
Purpose
The purpose of this study is to discuss the efficacy and safety of recombinant human
endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus cisplatin
or carboplatin in the first-line treatment of advanced lung adenocarcinoma with wild-type
EGFR or ALK-negative,compared with chemotherapy without endostar.
Detailed Description
With the progress of molecular biology and translational medical research, the treatment of
advanced non-small cell lung cancer goes into the era of personalized medicine. Lung
adenocarcinoma accounts for about 50% of non-small cell lung cancer.In recent years, although
individualized targeted therapy in lung adenocarcinoma progress by leaps and bounds, but the
research of wild-type EGFR or ALK-negative lung adenocarcinoma is extremely lag, lack of
clinically effective targeted drugs.As time goes on,almost all of the EGFR-TKI treatment of
lung adenocarcinoma will be resistant one day,and patients need other treatments, such as
chemotherapy.Currently, chemotherapy is still the main treatment for advanced lung
adenocarcinoma with EGFR wild-type and unkown.Many researches has reported that:endostar
combined with chemotherapy in patients with advanced NSCLC can significantly improve the
patient's RR,TTP and did not increase the adverse effects of chemotherapy.Recently,endostar
durative intravenous transfusion has been widely accept and use because of the lower
toxicity.The purpose of our study was to discuss the efficacy and safety of endostard
durative intravenous transfusion combined with chemotherapy.In our study,Patients with Ⅲb/Ⅳ
lung adenocarcinoma were divided into two groups randomly,one group was treated with endostar
durative intravenous transfusion combined with chemotherapy,while the other group with
chemotherapy pemetrexed plus cisplatin or carboplatin only.In the end,PFS,ORR,DCR and OS were
compared between these two groups.
Trial Arms
Name | Type | Description | Interventions |
---|
endostar and chemotherapy group | Experimental | recombinant human endostatin(endostar) injection was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 per one day,every 21 days of a cycle,combined with pemetrexed plus cisplatin or carboplatin. | - recombinant human endostatin
- pemetrexed plus cisplatin or carboplatin
|
chemotherapy group | Active Comparator | pemetrexed injection was intravenous with the dose of 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin,without recombinant human endostatin. | - pemetrexed plus cisplatin or carboplatin
|
Eligibility Criteria
Inclusion Criteria:
- 1) histologically confirmed (patients not receiving a single sputum cytology
diagnosis) non-small cell lung cancer patients,with wild-type EGFR and ALK-negative;
2) According to IASLC2009 new TNM staging of lung cancer stage ⅢB or Ⅳ, previously
untreated or relapsed after 1 year of lung cancer resection; 3) have at least one
evaluable lesions,according to version 1.1 of the standard in accordance with a
judgment RECIST(longest diameter on a spiral CT at least 10mm,on a regular CT longest
diameter at least 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 or 1; 6)
expected survival at least 3 months; 7) adequate hematological function: absolute
neutrophil count (ANC) at least 2×10^9/L and platelet count at least 100×10^9/L and
hemoglobin at least 9 g/dL; 8) adequate liver function: total bilirubin less than
upper limit of normal (ULN); AST and ALT less than 2.5 times upper limit of normal
(ULN); alkaline phosphatase less than 5 times the upper limit of normal (ULN); 9)
adequate renal function: serum creatinine less than upper limit of normal (ULN) or
calculated creatinine clearance at least 60 mL/min; 10) ECG is normal, there is no
non-healing wounds on the body; 11) had not received previous treatment anticancer
drugs, or had only received for previous non-metastatic tumors adjuvant or neoadjuvant
chemotherapy, but when you start to study treatment has ended more than 6 months; 12)
have conducted previous surgery patients required to study treatment was started more
than four weeks, and the patient had recovered; 13) have an intact uterus in women
prior to enrollment in the study must have a negative pregnancy test result (unless it
is already 24 months of amenorrhea) within 28 days. If the pregnancy test from the
first administration more than seven days, urine pregnancy test is required for
authentication (less than 7 days before the first dose); 14) previous to biological
agents, particularly E.coli genetically engineered products without serious allergic
reactions; 15) signed informed consent.
Exclusion Criteria:
- 1) pregnancy, breast-feeding women, or female patients of childbearing potential but
did not take contraceptive measures;2) existing severe acute infection and is not
controlled; or purulent and chronic infection, delayed healing wounds; 3) the original
severe heart disease, including congestive heart failure, uncontrolled high-risk
arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and
resistant hypertension; 4) suffering from neurological and psychiatric diseases or
mental disorders is not easy to control, poor compliance, and can not be described
with treatment responders; primary brain or central nervous metastasis disease has not
been controlled, with significant cranial hypertension or neuropsychiatric symptoms;
5) have bleeding tendencies; 6) other researchers believe that patients should not
participate in the present trial.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | progression free survival |
Time Frame: | Throughout the study period,an average of 1.5 year |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | objective response rate |
Time Frame: | Throughout the study period,an average of 1.5 year |
Safety Issue: | |
Description: | |
Measure: | disease control rate |
Time Frame: | Throughout the study period,an average of 1.5 year |
Safety Issue: | |
Description: | |
Measure: | overall survival |
Time Frame: | after the study finished,an average of 2 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Anhui Provincial Hospital |
Trial Keywords
- Recombinant human endostatin(Endostar)
- Durative transfusion
- adenocarcinoma of lung
Last Updated
June 21, 2016