Unresectable advanced pancreatic cancer
Conditions
Interventions
STNM01 will be diluted with physiological saline. Study drug will be administered using EUS-FNI technique to the tumor lesion. The patients will be received 250 nM of STNM01. Eligible subjects will be
Sponsors
Tokyo Metropolitan Geriatric Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The subject has an unresectable diagnosed pancreatic cancer. 2)The subject has been treated before the screening tests by conventional drug(s) generally used to treat pancreatic cancer [e.g., Gemicitabine, S-1]. In the opinion of his primary doctor, the subject has experienced an insufficient response or resistance to the current conventional treatment. The insufficient response or resistance to the current treatment is also confirmed by the principal investigator of this study. The experiencing an "insufficient response or resistance" can be assessed at the primary doctors and principal investigator's discretion. 3)The subject has measurable disease. Patients must have clinically and/or radiographically documented measurable disease. 4)The subject has an ECOG performance status of 0~1. 5)The subjects age is 20 or older and under 65 at the time of informed consent. 6)The subject is able to intraoral intake. 7)The subject has fully organ function. 8)The subject signs and dates a written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1)The subject has or has a history of serious cardiac, hematological or pulmonary disease, and is unsuitable, in the investigator's opinion, to participate in the study. 2)The subject has moderate to severe ascites and/or pleural effusion. 3)The subject has or has a history of metastatic brain tumor. 4)The subject has or has a history of multiple primary cancers. 5)The subject has a complication of serious infection that requires hospitalization. 6)The subject has a hepatic impairment or renal disorder, and is unsuitable, in the investigator's opinion, to participate in the study. 7)The subject has a bleeding tendency. 8)The subject has a history of clinically serious allergic symptom. "Serious" means an allergic symptom causing generalized hives, anaphylaxis or shock requiring hospitalization, when exposed to a specific antigen or drug. 9)The subject is currently participating or plans to participate in another clinical study during the course of this study. 10)The subject has any psychiatric or neurological disorder, and is unsuitable, in the investigator's opinion, to participate in the study. 11)The subject is incapable of or restricted to the protocol-directed examinations or procedures. 12)The subject is considered by the investigator, for any other reason, to be unsuitable for participating in this study. 13) For females: pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects and adverse drug reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor responce Palliative benefit PFS(Long-term observation) Plasma drug concentrations | — |
Countries
Japan
Contacts
Public ContactMakoto Nishimura
Tokyo Metropolitan Geriatric Hospital Department of gastrointestinal endoscopy
Outcome results
None listed