Phase II randomised clinical trial of personalized peptide vaccination in combination with Dai-kenchu-to for colorectal cancer patients resistant to standard therapies.

ABSTRACT: Interventions: arm1: The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund’s adjuvant every week (3.0 mg/each peptide; 6 times/cycle). Dai-kenchu-to(5 g/time, 3 times/day) will be orally administered from the date of the first vaccination to the date of the sixth vaccination. If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2-4 weeks). arm2: The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund’s adjuvant every week (3.0 mg/each peptide; 6 times/cycle). If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2-4 weeks). Primary outcome(s): Comparison of immune-enhancing effects (changes in anti-peptide IgG titers in plasma)between two groups. Study Design: Parallel Randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2623536 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR