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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008126

Enrollment

Registered

2012-06-08

Start date

2012-06-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

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 befo

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

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).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as colorectal cancer resistant to standard therapies. Measurable lesions are not required. 2) Patients must be at a score level 0-1 of ECOG performance status. 3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types. 4)Patients must be expected to survive more than 3 months. 5) Patient's laboratory data must satisfy the followings: WBC is more than 2,500/mm3 Lymphocyte is more than 1,000/mm3 Hb is more than 8.0g/dl Platelet is more than 50,000/mm3 Serum Creatinine is less than 2.0mg/dl AST(GOT),ALT(GPT),ALP,gGTP, and total bilirubin are less than 2 times the ULN. 6) Patients must be more 20 year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Comparison of immune-enhancing effects (changes in anti-peptide IgG titers in plasma)between two groups.	—

Secondary

Measure	Time frame
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 .	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7572

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026