Phase II randomised clinical trial of personalized peptide vaccination in combination with Dai-kenchu-to for colorectal cancer patients resistant to standard therapies.
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000008126
- 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
- 60
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 the interstitial pneumonia or with the past history of this disease. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of immune-enhancing effects (changes in anti-peptide IgG titers in plasma)between two groups.
- Secondary Outcome Measures
Name Time Method 1.Comparison of peptide-specific CTL responses in PBMCs between two groups. 2. Comparison of safety between two groups. 3. Comparison of overall survival between two groups .