Phase II randomised clinical trial of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies .
- Conditions
- lung cancer
- Registration Number
- JPRN-UMIN000008940
- Lead Sponsor
- Kurume University Cancer Vaccine Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
The following patients must be excluded: 1)Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, ranal diseases, immunodeficiencies, disturbance of coagulation, et al). 2)Active double cancer(synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ(lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 3)Patients with the past history of severe allergic reactions. 4)patients with pulmonary disorder (idiopathic pulmonary fibrosis,interstitial pneumonia,pneumoconiosis,radiation pneumonia,drug-induced pneumonia). 5)(Females) Pregnant or nursing patients. Patients desiring future fertility. (Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 6)Patients who are judged inappropriate for entry to this clinical trial by doctors. 7)Patients who has taken Ninjin-yoei-to.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of immune-enhancing effects between two groups.
- Secondary Outcome Measures
Name Time Method 1. Comparison of safety between two groups. 2. Comparison of overall survival between two groups .