Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma

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

Brief Summary

      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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

progression free survival

Secondary Outcome

 objective response rate

Condition

Adenocarcinoma of Lung

Intervention

recombinant human endostatin

Study Arms / Comparison Groups

 endostar and chemotherapy group

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

100

Start Date

June 2016

Completion Date

December 2018

Primary Completion Date

December 2017

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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Lejie Cao, professor, , [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT02804646

Organization ID

20160606

Responsible Party

Sponsor

Study Sponsor

Anhui Provincial Hospital

Study Sponsor

Lejie Cao, professor, Principal Investigator, Anhui Provincial Hospital

Verification Date

June 2016