NCT02493582Active, not recruitingPhase 2
The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR
The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR
Source: ClinicalTrials.gov · Last updated 5 Feb 2016
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 7 Jul 2015
- Start date
- Jul 2015
- Primary completion date
- Jul 2030
- Lead sponsor
- The First People's Hospital of Changzhou
- Diseases
- Lung cancer
- NCT number
- NCT02493582
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 400
- From Jul 2015 to the primary completion date, Jul 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have previously received TKIs
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Other concurrent uncontrolled illness
Other illness
- Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
- Small cell lung cancer
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
- Patients who are suffering from serious autoimmune disease
- Patients who had active infection
- Patients who are suffering from other cancer
Lab values
- Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
Other
- Pregnant or lactating patients
- Patients who had used long time or are using immunosuppressant
- Patients who are suffering from serious organ dysfunction
- Other situations that the researchers considered unsuitable for this study.
Who the study is looking for
- Histologically or cytologically confirmed Lung adenocarcinoma
- Wld-type EGFR
- Stage IIIB/IV
- Failure to prior chemotherapy
- Life expectancy of more than 3 months
- Tissue sample desired for genomic study
- Age ≥ 18 years
- Performance status (WHO) \< 3
- Adequate bone marrow function (absolute neutrophil count\>1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9gr/mm\^3)
- Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
- Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- Informed consent
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.