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Phase 1 study of HSP105-derived peptide vaccine for patients with advanced esophageal cancer/ colo- rectal cancer.

Phase 1
Conditions
advanced esophageal cancer/ colo- rectal cancer
Registration Number
JPRN-UMIN000017809
Lead Sponsor
ational Cancer Center Hospital East
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

1) Pleural effusion or ascites required invasive treatment. 2) Chemotherapy within 4 weeks prior to enrollment. 3) Active infection requires systemic therapy. 4) Any severe medical conditions. 5) Historical or coexisting severe interstitial pneumonia. 6) Severe psychiatric disorder. 7) Women during pregnancy or lactation , 8) Known serious drug allergy. 9) Positive HBs antigen or HCV antibody or HIV antibody within 6 months prior to enrollment. 10) Received the continuous whole body dosage (oral or intravenous) with steroid and other immunosuppressive drugs. 11) Patient is judged by the investigator to be inappropriate for study participation for any reason.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
P1a:Proportion of dose limiting toxicity P1b:Response rate
Secondary Outcome Measures
NameTimeMethod
Progression free survival Treatment failure rate Adverse events Immunological effects
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