advanced esophageal cancer/ colo- rectal cancer
Conditions
Interventions
HSP105-derived peptide vaccine is administered weekly by intradermal injection, for a maximum of 1 year.
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma of esophagus/adenocarcinoma of colon or rectum 2) Prior chemotherapy was discontinued due to disease progression, or an adverse event. 3) >=20 years old, <=75 years old 4) ECOG Performance Status of 0 or 1 5) With measurable disease according to RECIST ver 1.1. 6) Adequate organ function within 14 days prior to enrollment. a. Hemoglobin >=8.0 g/dL b. Absolute neutrophil >=1,500/mm3 c. Platelet >=75,000/mm3 d Total bilirubin <=1.5 mg/dL e. AST <=100 U/L (with liver metastasis, AST <=200U/L) f. ALT <=100 U/L (with liver metastasis, ALT <=200U/L) g. Serum creatinine <=1.5mg/dL 7) Blood transfusion not within 14 days prior to enrollment. 8) Positive one either or more of HLA-A*24:02, 02:01, 02:06 , 02:07. 9) Recovered AEs related to prior treatment are Grade >= 1 according to CTCAE. (excluded alopecia, peripheral sensory neuropathy, skin hyperpigmentation, and dysgeusia) 10) Women of childbearing potential must have a negative pregnancy test within 14 days prior to enrollment. 11) Written informed consent
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| P1a:Proportion of dose limiting toxicity P1b:Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Treatment failure rate Adverse events Immunological effects | — |
Countries
Japan
Contacts
Public ContactTakashi Kojima
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed