Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy

Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy - Phase I/II study of peptide vaccination in combination with TS-1 for metastatic colorectal cancer with KRAS genetic mutation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002856

Enrollment

Registered

2010-01-01

Start date

2009-12-01

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

KRAS genetic sequence, peptide vaccination, TS1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically diagnosed colorectal cancer 2. contains metastatic lesions that can be estimated by RECIST. 3. undertook first-line and second-line therapies that contained oxaliplatin and CPT-11. 4. contains tumor in which KRAS gene codon 12 or 13 is mutated. 5. HLA-A2402 6. PS=0 or 1 (ECOG) 7. written informed consent 8. WBC >= 3,000 and <=12,000 Platelet >=100,000/mm3 lymphocytes >=1,000 GOT(AST) <=100 IU/L GPT(ALT) <=100 IU/L Serum Creatinine<= 1.2 mg/dl Total Bilirubin <=1.5 mg/dl Creatinine clearance >=50 ml/min (Cock-Gault)

Exclusion criteria

Exclusion criteria: 1. active double cancer(s) 2. undertook radiation therapy for abdominal lesions. 3. HIV-positive patients 4. sever comorbidity (intestinal obstruction, uncontrolled Diabetes M., uncontrolled hypertension, Angina P., liver cirrhosis, pneumonitis, emphysema, etc) 5. allergy for TS1 6. ascites or pleural effusion that needs to be treated 7. patients with bleeding 8. patients treated with fruitosin 9. pregnant woman

Design outcomes

Primary

Measure	Time frame
First step (clinical phase I) Primary Endpoint: RD Second step (clinical phase II) Primary Endpoint: DCR	—

Secondary

Measure	Time frame
First step (clinical phase I) Secondary Endpoint: AE, immunological reactions by peptide vaccine (CTL, CD8, reg T) Second step (clinical phase II) Secondary Endpoint: RR, OS, PFS, TTF, AE, immunological reactions by peptide vaccine (CTL, CD8, reg T)	—

Countries

Japan

Outcome results

None listed

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